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idK150617_s0_e2000

K150617.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Classification:

idK150617_s0_e2000

K150617.txt

product code

OQO

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Product code:

idK150617_s0_e2000

K150617.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Panel:

idK150617_s0_e2000

K150617.txt

predicate device name

BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Predicate device name:

idK150617_s0_e2000

K150617.txt

applicant

Roche Molecular Systems, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Applicant:

idK150617_s0_e2000

K150617.txt

proprietary and established names

cobas® HSV 1 and 2 Test

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Proprietary and established names:

idK150617_s0_e2000

K150617.txt

regulation section

21 CFR 866.3305

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150617 B. Purpose for Submission: Clearance of New Device C. Measurand: Target DNA sequences from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) D. Type of Test: An in vitro molecular diagnostic test for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® HSV 1 and 2 Test G. Regulatory Information: 1. Regulation section: 21 CFR 866.3305 2. Classification: Class II 3. Product code: OQO 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) 2 DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: cobas® 4800 System I. Device Description: The cobas® HSV 1 and 2 Test on the cobas® 4800 system is a real-time polymerase chain reaction (PCR) for the direct detection and differentiation of HSV-1 and HSV-2 DNA in clinician-collected, external anogenital lesion specimens, collected in MSwab Collection, Transport and Preservation System from symptomatic patients. The cobas® HSV 1 and HSV 2 Test is comprised of two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An internal control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process. The specimens are collected and stored in the MSwab Collection, Transport and Preservation System for the cobas® HSV 1 and HSV 2 Test. The cobas® HSV 1 and HSV 2 Test is performed using the following reagent kits: 1. cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 2. cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 3. cobas® 4800 System Wash Buffer Kit 4. cobas® 4800 System Lysis Kit 1 5. cobas® 4800 System Internal Control Kit 1 6. cobas® 4800 System Sample Preparation Kit 3 J. Substantial Equivalence Information: 1. Predicate device name(s): BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Reference Method: A composite reference method which includes a culture method, namely, the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)) and a validated PCR followed by bidirectional sequencing for clinical evaluation. The clinical performance of the cobas® HSV 1/2 Test was also compared to the culture method alone using the ELVIS® HSV ID/Typing Test System (Diagnostic Hybrids, Inc. (K971662)). 2. Predicate 510(k) number(s): K103798 3. Comparison with predicate: Similarities Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Intended use The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays), when tested with the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients. Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with 4 Warning: The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years. cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. Sample Types External anogenital lesions Same Assay Results Qualitative detection and differentiation of HSV-1 and HSV-2 DNA Same Detection Chemistry Paired reporter and quencher fluorescence labeled probes using fluorescence resonance energy transfer (FRET) Same Differences Characteristic BD ProbeTecTM Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays on the BD Viper System in Extracted Mode, (K103798) Roche cobas® HSV 1 and 2 Test New Device (K150617) Amplification Technology Strand Displacement Amplification Real-time PCR Sample Preparation Procedure Automated on BD™ Viper™ System in Extracted Mode Automated on cobas® 4800 System K. Standard/Guidance Document Referenced (if applicable): N/A 5 L. Test Principle: Target Selection The cobas® HSV 1and 2 Test utilizes real-time PCR technology to detect the conserved regions of HSV-1 Thymidine Kinase and HSV-1 DNA Polymerase as well as HSV-2 Thymidine Kinase and HSV-2 Glycoprotein B genes. Fluorogenic target-specific probes are used for the detection of the amplified HSV-1 and HSV-2 DNA as well as Internal Control. Since two HSV type targets are detected with different fluorescent dyes, the cobas® HSV 1 and 2 Test has the ability to simultaneously detect and differentiate HSV-1 and HSV-2. Primer and probe oligonucleotide sequences were designed to select HSV-1 and HSV-2 conserved sequences without cross reacting to other viruses, or other bacterial organisms commonly found in human genital areas. Sample Preparation Sample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Organisms from swab specimens collected in MSwab medium are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. The particles are washed and the bound nucleic acids are then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix. PCR Amplification and TaqMan® Detection The PCR cycling steps and detection of target signal occurs in the cobas® z 480 Analyzer. The Master Mix reagent contains primer pairs and probes for HSV-1, HSV-2 and Internal Control targets. If the target nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicons). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher Regulation section:

idK150617_s14000_e16000

K150617.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

be processed directly from primary collection vials or as aliquots of the specimen in secondary vials. See section I for more information on specimen handling. 5. Calibration: No calibration is required by the user. Roche technicians perform calibration periodically as required. 6. Quality Control: See section M.1.d for information on internal and external controls. P. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. Q. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150617_s14000_e16000

K150617.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

imens can be processed directly from primary collection vials or as aliquots of the specimen in secondary vials. See section I for more information on specimen handling. 5. Calibration: No calibration is required by the user. Roche technicians perform calibration periodically as required. 6. Quality Control: See section M.1.d for information on internal and external controls. P. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. Q. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK143736_s0_e2000

K143736.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Purpose for submission:

idK143736_s0_e2000

K143736.txt

measurand

Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Measurand:

idK143736_s0_e2000

K143736.txt

type of test

Immunoassay, qualitative and semi-quantitative

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Type of test:

idK143736_s0_e2000

K143736.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Classification:

idK143736_s0_e2000

K143736.txt

product code

DHR: System, Test, Rheumatoid Factor

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Product code:

idK143736_s0_e2000

K143736.txt

panel

Immunology (82)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Panel:

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K143736.txt

applicant

IMMCO Diagnostics, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Applicant:

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K143736.txt

regulation section

21 CFR §866.5775: Rheumatoid factor immunological test system

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K143736 B. Purpose for Submission: New device C. Measurand: Rheumatoid Factors (RF) IgA, IgG, IgM, and Rheumatoid Factor Total D. Type of Test: Immunoassay, qualitative and semi-quantitative E. Applicant: IMMCO Diagnostics, Inc. F. Proprietary and Established Names: ImmuLisa Enhanced™ RF IgA Antibody ELISA ImmuLisa Enhanced™ RF IgG Antibody ELISA ImmuLisa Enhanced™ RF IgM Antibody ELISA ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA G. Regulatory Information: 1. Regulation section: 21 CFR §866.5775: Rheumatoid factor immunological test system 2. Classification: Class II 3. Product code: DHR: System, Test, Rheumatoid Factor 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): ImmuLisa Enhanced™ RF IgA Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgG Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgM Antibody ELISA: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA: Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: A microplate reader capable of reading absorbance values at 450 nm. If a dual wavelength microplate reader is available, the reference filter should be set at 600-650 nm. An automatic microplate washer capable of accurately dispensing 200 μL of fluid is also required. I. Device Description: Each kit consists of one 12 x8 microplate with individual breakaway microwells coated with purified rabbit IgG antigen, a five-level calibrator set for semi-quantitative analysis, a cut-off calibrator for qualitative analysis, a negative control, a positive control, Tetramethylbenzidine (TMB) chromogenic substrate, stop solution, wash buffer, and diluent. 3 The type of conjugate is specific for each kit: goat anti-human IgA, HRP (horseradish peroxidase) conjugate for the RF IgA Antibody ELISA; goat anti-human IgG HRP conjugate for the RF IgG Antibody ELISA; goat anti-human IgM HRP conjugate for the RF IgM Antibody ELISA; and a mixture of goat anti-human IgA, IgG, and IgM HRP conjugates for the RF IgA/IgG/IgM ELISA. J. Substantial Equivalence Information: 1. Predicate device name(s) and numbers: Inova QuantaLite® RF IgA ELISA, K983084 Inova QuantaLite® RF IgG ELISA, K983083 Inova QuantaLite® RF IgM ELISA, K971614 2. Comparison with predicates: Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Intended Use/Indication for Use Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings. Same Test Principle Enzyme-Linked Immunoassay (ELISA) Same Instrumentation Spectrophotometer reading at 450 nm Same Analyte RF IgA, IgG, or IgM antibodies Same Sample Type Serum Same Sample Dilution 1:101 Same Kit Components Includes positive controls, negative controls, calibrators, conjugates, substrate, diluent, wash buffer, stop solution, microplates Same Capture Antigen Rabbit IgG Same Detection Reagents HRP conjugated to goat anti-human IgA, IgG, or IgM Same Substrate TMB Same Incubation Times Positive and negative controls and diluted patient samples: 30 min Same 4 Similarities Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/ IgG/IgM ELISA Conjugate: 30 min Substrate: 30 min (in dark) Stop Solution Sulfuric acid (H2SO4) Same Controls Positive Controls: human sera positive for RF IgA, IgG, IgM, or total RF Negative Controls: human sera negative for RF IgA, IgG, IgM, or total RF Same Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA Measurement Type RF IgA, IgG, and IgM Antibody ELISAs: Qualitative and semi-quantitative RF IgA/IgG/IgM ELISA: Qualitative only Semi-Quantitative Wash buffer Powdered or optional liquid concentrate Liquid concentrate Calibrators RF IgA and IgG Antibody ELISAs: Set of five vials with values in EU/ml: 1, 20, 40, 80, 160 RF IgM Antibody ELISA: Set of five vials with values in IU/mL: 1, 10, 20, 40, 80 RF IgA/IgG/IgM ELISA: 30 EU/mL (1- point calibration) Set of five vials with value in units: 5, 12.5, 25, 50, 100 Reagent Stability Reagents: until the expiration date at 2– 8°C Reconstituted wash buffer: until the kit expiration date at 2–8°C Reagents: until the expiration date at 2–8°C Diluted wash buffer: 1 week at 2–8°C Cut-offs RF IgA/IgG and RF IgA/IgG/IgM ELISAs: 20 EU/mL RF IgM Antibody ELISA: 10 IU/mL IgA, IgG, and IgM ELISAs: 6 Units Linear Ranges RF IgA Antibody ELISA: 3.7–160 EU/mL RF IgG Antibody ELISA: 2.2–160 EU/mL RF IgM Antibody ELISA: 1.3–80 IU/mL Not Specified Limits of Blank RF IgA Antibody ELISA: 3.2 EU/mL RF IgG Antibody ELISA: 1.5 EU/mL RF IgM Antibody ELISA: 1.2 IU/mL RF IgA/IgG/IgM ELISA: 2.1 EU/mL Not Specified Limits of Detection RF IgA Antibody ELISA: 3.7 EU/mL RF IgG Antibody ELISA: 2.2 EU/mL Not Specified 5 Differences Item New Devices: ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISAs and RF IgA/IgG/IgM ELISA Predicates: Inova QuantaLite® RF IgA/IgG/IgM ELISA RF IgM Antibody ELISA: 1.3 IU/mL RF IgA/IgG/IgM ELISA: 2.7 EU/mL Traceability RF IgA and IgG Antibody ELISAs: Reference standard or method is not available. Results are traceable to in-house standards. RF IgM Antibody ELISA: traceable Regulation section:

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K143736.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

CI: 87.6%–94.8% Overall Percent Agreement 90.9% 95% CI: 87.8%–93.2% n = 184 Rheumatoid Arthritis Samples, n = 243 Disease Control Samples b. Matrix comparison: Not applicable since human serum is the only claimed specimen matrix. 3. Clinical studies: a. Clinical Sensitivity and Specificity: The performances of the ImmuLisa Enhanced™ RF Antibody and RF IgA/IgG/IgM ELISAs were compared to a clinical diagnosis of RA. The validation set consisted of 179–249 clinically characterized sera from RA and 310 disease controls. Clinical sensitivity and specificity were calculated with 95% confidence intervals (95% CI). Clinical sensitivity and specificity were calculated by grouping ImmuLisa Enhanced™ RF IgA, IgG, and IgM Antibody semi-quantitative ELISA indeterminate results with both the positive and the negative results separately. The data presented in the tables below represent results from the semi-quantitative ImmuLisa Enhanced™ RF Antibody IgA, IgG, and IgM ELISAs. Results were also calculated using the qualitative IgA, IgG, and IgM ELISAs and found to be identical to the results from the semi-quantitative ELISAs. 21 ImmuLisa Enhanced™ RF IgA Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA Antibody ELISA Positive: >20 EU/mL 131 33 164 Negative: ≤20 EU/mL 118 277 395 Total 249 310 559 Sensitivity 52.6% 95% CI: 46.4%–58.7% Specificity 89.4% 95% CI: 85.4%–92.3% ImmuLisa Enhanced™ RF IgA Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA Antibody ELISA Positive: ≥25 EU/mL 115 23 138 Negative: <25 EU/mL 134 287 421 Total 249 310 559 Sensitivity 46.2% 95% CI: 40.1%–52.4% Specificity 92.6% 95% CI: 89.1%–95.0% ImmuLisa Enhanced™ RF IgG Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgG Antibody ELISA Positive: >20 EU/mL 126 23 149 Negative: ≤20 EU/mL 123 287 410 Total 249 310 559 Sensitivity 50.6% 95% CI: 44.4%–56.8% Specificity 92.6% 95% CI: 89.1%–95.0% 22 ImmuLisa Enhanced™ RF IgG Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgG Antibody ELISA Positive: ≥25 EU/mL 98 16 114 Negative: <25 EU/mL 151 294 445 Total 249 310 559 Sensitivity 39.4% 95% CI: 33.5%–45.5% Specificity 94.8% 95% CI: 91.8%–96.8% ImmuLisa Enhanced™ RF IgM Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgM Antibody ELISA Positive: >20 EU/mL 176 39 215 Negative: ≤20 EU/mL 73 271 344 Total 249 310 559 Sensitivity 70.7% 95% CI: 64.7%–76.0% Specificity 87.4% 95% CI: 83.3%–90.7% ImmuLisa Enhanced™ RF IgM Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgM Antibody ELISA Positive: ≥25 EU/mL 159 36 195 Negative: <25 EU/mL 90 274 364 Total 249 310 559 Sensitivity 63.9% 95% CI: 57.7%–69.6% Specificity 88.4% 95% CI: 84.3%–91.5% 23 ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA Positive: ≥25 EU/mL 152 45 197 Negative: <25 EU/mL 27 265 292 Total 179 310 489 Sensitivity 84.9% 95% CI: 78.9%–89.4% Specificity 85.5% 95% CI: 81.1%–89.0% b. Incidence of cross-reactivity in related autoimmune and infectious diseases A total of 310 samples from related autoimmune and infectious diseases were tested with each ImmuLisa Enhanced™ RF Antibody ELISA and the ImmuLisa Enhanced™ IgA/IgG/IgM ELISA to determine incidence of positive results. Results are presented in the table below: Clinical Diagnosis # Samples % Positive RF IgA RF IgG RF IgM RF IgA/IgG/ IgM Juvenile Arthritis 10 0% 10% 10% 10% Osteoarthritis 30 0% 0% 3% 0% Psoriatic Arthritis 33 6% 9% 6% 6% Spondyloarthritis 33 3% 0% 3% 3% Mixed Connective Tissue Disease 10 10% 20% 40% 30% Churg‐Strauss 10 10% 10% 10% 20% Sjögren's Syndrome 20 45% 10% 55% 45% Systemic Lupus Erythematosus 30 37% 20% 17% 40% Systemic Sclerosis 20 15% 20% 25% 25% Wegener's 8 13% 13% 13% 13% Celiac Disease 8 0% 0% 0% 0% Graves’ Disease 10 0% 10% 10% 10% Hashimoto’s Disease 8 0% 0% 0% 0% Ulcerative Colitis 10 0% 10% 0% 10% Syphilis 10 0% 0% 0% 0% Rubella 10 0% 0% 10% 10% Mononucleosis 5 20% 0% 0% 0% 24 Clinical Diagnosis # Samples % Positive RF IgA RF IgG RF IgM RF IgA/IgG/ IgM Lyme 5 0% 0% 0% 0% HCV 10 10% 10% 20% 30% CMV 10 0% 0% 0% 10% HSV 10 10% 0% 20% 10% Toxoplasmosis 10 10% 0% 10% 10% 4. Clinical cut-off: See Assay Cut-Off 5. Expected values/Reference range: A reference range study was performed with 62–80 normal human serum samples, and a verification study with 121–137 samples that were a combination of normal human sera and sera from patients with infectious diseases and other autoimmune conditions that were not RA (disease controls). The upper limit of the optical density (OD) results from the normal samples was calculated using the average plus 2 standard deviations for ImmuLisa Enhanced™ RF IgA and IgG ELISAs, and the average plus 2.5 standard deviations for ImmuLisa Enhanced™ RF IgM and IgA/IgG/IgM ELISAs. This OD was set to 20 EU/mL for the IgA, IgG, and IgA/IgG/IgM ELISA, and 10 IU/mL for the IgM ELISA. The data from the verification study are summarized in the table below: ImmuLisa Enhanced™ RF Antibody # of Samples % Samples Negative % Samples Indeterminate % Samples Positive IgA 127 94.5% 3.9% 1.6% IgG 121 99.0% 1.0% 0.0% IgM 137 99.0% 1.0% 0.0% IgA/IgG/IgM 137 100.0% 0.0% 0.0% N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK143736_s10000_e12000

K143736.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

95% CI: 87.6%–94.8% Overall Percent Agreement 90.9% 95% CI: 87.8%–93.2% n = 184 Rheumatoid Arthritis Samples, n = 243 Disease Control Samples b. Matrix comparison: Not applicable since human serum is the only claimed specimen matrix. 3. Clinical studies: a. Clinical Sensitivity and Specificity: The performances of the ImmuLisa Enhanced™ RF Antibody and RF IgA/IgG/IgM ELISAs were compared to a clinical diagnosis of RA. The validation set consisted of 179–249 clinically characterized sera from RA and 310 disease controls. Clinical sensitivity and specificity were calculated with 95% confidence intervals (95% CI). Clinical sensitivity and specificity were calculated by grouping ImmuLisa Enhanced™ RF IgA, IgG, and IgM Antibody semi-quantitative ELISA indeterminate results with both the positive and the negative results separately. The data presented in the tables below represent results from the semi-quantitative ImmuLisa Enhanced™ RF Antibody IgA, IgG, and IgM ELISAs. Results were also calculated using the qualitative IgA, IgG, and IgM ELISAs and found to be identical to the results from the semi-quantitative ELISAs. 21 ImmuLisa Enhanced™ RF IgA Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA Antibody ELISA Positive: >20 EU/mL 131 33 164 Negative: ≤20 EU/mL 118 277 395 Total 249 310 559 Sensitivity 52.6% 95% CI: 46.4%–58.7% Specificity 89.4% 95% CI: 85.4%–92.3% ImmuLisa Enhanced™ RF IgA Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA Antibody ELISA Positive: ≥25 EU/mL 115 23 138 Negative: <25 EU/mL 134 287 421 Total 249 310 559 Sensitivity 46.2% 95% CI: 40.1%–52.4% Specificity 92.6% 95% CI: 89.1%–95.0% ImmuLisa Enhanced™ RF IgG Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgG Antibody ELISA Positive: >20 EU/mL 126 23 149 Negative: ≤20 EU/mL 123 287 410 Total 249 310 559 Sensitivity 50.6% 95% CI: 44.4%–56.8% Specificity 92.6% 95% CI: 89.1%–95.0% 22 ImmuLisa Enhanced™ RF IgG Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgG Antibody ELISA Positive: ≥25 EU/mL 98 16 114 Negative: <25 EU/mL 151 294 445 Total 249 310 559 Sensitivity 39.4% 95% CI: 33.5%–45.5% Specificity 94.8% 95% CI: 91.8%–96.8% ImmuLisa Enhanced™ RF IgM Antibody ELISA Indeterminate Samples Called Positive RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgM Antibody ELISA Positive: >20 EU/mL 176 39 215 Negative: ≤20 EU/mL 73 271 344 Total 249 310 559 Sensitivity 70.7% 95% CI: 64.7%–76.0% Specificity 87.4% 95% CI: 83.3%–90.7% ImmuLisa Enhanced™ RF IgM Antibody ELISA Indeterminate Samples Called Negative RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgM Antibody ELISA Positive: ≥25 EU/mL 159 36 195 Negative: <25 EU/mL 90 274 364 Total 249 310 559 Sensitivity 63.9% 95% CI: 57.7%–69.6% Specificity 88.4% 95% CI: 84.3%–91.5% 23 ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA RA Diagnosis Positive Negative Total ImmuLisa Enhanced™ RF IgA/IgG/IgM ELISA Positive: ≥25 EU/mL 152 45 197 Negative: <25 EU/mL 27 265 292 Total 179 310 489 Sensitivity 84.9% 95% CI: 78.9%–89.4% Specificity 85.5% 95% CI: 81.1%–89.0% b. Incidence of cross-reactivity in related autoimmune and infectious diseases A total of 310 samples from related autoimmune and infectious diseases were tested with each ImmuLisa Enhanced™ RF Antibody ELISA and the ImmuLisa Enhanced™ IgA/IgG/IgM ELISA to determine incidence of positive results. Results are presented in the table below: Clinical Diagnosis # Samples % Positive RF IgA RF IgG RF IgM RF IgA/IgG/ IgM Juvenile Arthritis 10 0% 10% 10% 10% Osteoarthritis 30 0% 0% 3% 0% Psoriatic Arthritis 33 6% 9% 6% 6% Spondyloarthritis 33 3% 0% 3% 3% Mixed Connective Tissue Disease 10 10% 20% 40% 30% Churg‐Strauss 10 10% 10% 10% 20% Sjögren's Syndrome 20 45% 10% 55% 45% Systemic Lupus Erythematosus 30 37% 20% 17% 40% Systemic Sclerosis 20 15% 20% 25% 25% Wegener's 8 13% 13% 13% 13% Celiac Disease 8 0% 0% 0% 0% Graves’ Disease 10 0% 10% 10% 10% Hashimoto’s Disease 8 0% 0% 0% 0% Ulcerative Colitis 10 0% 10% 0% 10% Syphilis 10 0% 0% 0% 0% Rubella 10 0% 0% 10% 10% Mononucleosis 5 20% 0% 0% 0% 24 Clinical Diagnosis # Samples % Positive RF IgA RF IgG RF IgM RF IgA/IgG/ IgM Lyme 5 0% 0% 0% 0% HCV 10 10% 10% 20% 30% CMV 10 0% 0% 0% 10% HSV 10 10% 0% 20% 10% Toxoplasmosis 10 10% 0% 10% 10% 4. Clinical cut-off: See Assay Cut-Off 5. Expected values/Reference range: A reference range study was performed with 62–80 normal human serum samples, and a verification study with 121–137 samples that were a combination of normal human sera and sera from patients with infectious diseases and other autoimmune conditions that were not RA (disease controls). The upper limit of the optical density (OD) results from the normal samples was calculated using the average plus 2 standard deviations for ImmuLisa Enhanced™ RF IgA and IgG ELISAs, and the average plus 2.5 standard deviations for ImmuLisa Enhanced™ RF IgM and IgA/IgG/IgM ELISAs. This OD was set to 20 EU/mL for the IgA, IgG, and IgA/IgG/IgM ELISA, and 10 IU/mL for the IgM ELISA. The data from the verification study are summarized in the table below: ImmuLisa Enhanced™ RF Antibody # of Samples % Samples Negative % Samples Indeterminate % Samples Positive IgA 127 94.5% 3.9% 1.6% IgG 121 99.0% 1.0% 0.0% IgM 137 99.0% 1.0% 0.0% IgA/IgG/IgM 137 100.0% 0.0% 0.0% N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK181889_s0_e2000

K181889.txt

purpose for submission

To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms

SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Purpose for submission:

idK181889_s0_e2000

K181889.txt

measurand

Penicillin 0.002-32 μg/mL

SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Measurand:

idK181889_s0_e2000

K181889.txt

type of test

Quantitative Antimicrobial Susceptibility Test growth-based detection

) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Type of test:

idK181889_s0_e2000

K181889.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Classification:

idK181889_s0_e2000

K181889.txt

product code

JWY - Manual Antimicrobial Susceptibility Test Systems

k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Product code:

idK181889_s0_e2000

K181889.txt

panel

83 – Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Panel:

idK181889_s0_e2000

K181889.txt

predicate device name

Liofilchem MTS, vancomycin

SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Predicate device name:

idK181889_s0_e2000

K181889.txt

applicant

Liofilchem s.r.l.

k) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Applicant:

idK181889_s0_e2000

K181889.txt

proprietary and established names

MTS Penicillin 0.002-32 μg/mL

ANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Proprietary and established names:

idK181889_s0_e2000

K181889.txt

regulation section

866.1640 Antimicrobial Susceptibility Test Powder

) SUBSTANTIAL EQUIVALENCE DETERMINATIONS DECISION SUMMARY A. 510(k) Number: K181889 B. Purpose for Submission: To obtain a substantial equivalence determination for Penicillin (P) at concentrations of 0.002-32 µg/mL for susceptibility testing of fastidious Gram-positive organisms C. Measurand: Penicillin 0.002-32 μg/mL D. Type of Test: Quantitative Antimicrobial Susceptibility Test growth-based detection E. Applicant: Liofilchem s.r.l. F. Proprietary and Established Names: MTS Penicillin 0.002-32 μg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: JWY - Manual Antimicrobial Susceptibility Test Systems 4. Panel: 83 – Microbiology 2 H. Intended Use: 1. Intended use(s): The Liofilchem® MTS (MIC Test Strip) Penicillin 0.002-32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Penicillin at concentrations of 0.002 - 32 μg/mL should be interpreted at 20- 24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to th e FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Group C & G) Streptococcus anginosus (Group C & G) Streptococcus constellatus (Group C & G) Streptococcus intermedius (Group C & G) 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): · For prescription use · The ability of the MTS to detect resistant isolates with the following drug/bacterial species combinations is unknown because resistant isolates were either not available or an insufficient number was encountered at the time of comparative testing. Penicillin: Streptococcus pyogenes (Group A) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G) 3 4. Special instrument requirements: Manual reading only I. Device Description: The Penicillin MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of Penicillin across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. One side of the strip is labelled with the Penicillin code (P) and the MIC reading scale in µg/mL. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. Since MTS strip generates MIC values which fall between two-fold dilutions for interpretation, the MIC value read is recorded to the next two-fold dilution value. J. Substantial Equivalence Information: 1. Predicate device name(s): Liofilchem MTS, vancomycin 2. Predicate 510(k) number(s): K153687 4 3. Comparison with predicate: Table 1: Comparison with the Predicate Device Similarities Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Intended Use Quantitative susceptibility to antimicrobial agents Same Inoculum Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum Same Reading Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip Same Result MIC (µg/mL) Same Differences Item Device Liofilchem MTS, Penicillin (K181889) Predicate Liofilchem MTS, vancomycin (K153687) Media Mueller Hinton Agar with 5% sheep blood Mueller Hinton Agar Antibiotic Penicillin code (P) Vancomycin code (VA) Incubation 35 ± 2°C for 20 – 24 hours 35 ± 2°C for 24 hours K. Standard/Guidance Document Referenced: · Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. · CLSI M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015”. · CLSI M100-S26 “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016”. L. Test Principle: The Liofilchem MIC Test Strips (MTS) are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions similar to dilutions used by conventional MIC methods. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 20-24 hours incubation (time specific to Liofilchem MTS, Penicillin), a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of µg/mL at the point where the 5 edge of the inhibition ellipse intersects the strip MIC Test Strip. Growth along the entire gradient (i.e., no inhibition ellipse) indicates that the MIC value is greater than or equal to (≥) the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than (<) the lowest value. An MIC of 0.125μg/mL is considered to be the same as 0.12μg/mL for reporting purposes. An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two-fold value before categorization. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Reproducibility testing was conducted at three sites using ten Gram-positive organisms. Each isolate was tested in triplicate over three days. The reproducibility panel included four S. pyogenes, one S. anginosus, one S. constellatus, one S. intermedius, and three S. pneumoniae isolates. The mode MIC values were pre- determined and the reproducibility was calculated based on the number of MIC values that fell within ±1 doubling dilution of the mode MIC values. All MIC results were on scale. The testing resulted in overall reproducibility of 100%. The results were acceptable. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Quality Control (QC) Testing: The CLSI recommended QC strain, S. pneumoniae ATCC 49619, was tested a sufficient number of times (i.e., at least 20/site) at each testing site using both MTS and reference methods. The results are summarized in Table 2 below. The quality control results are acceptable. 6 Table 2: Quality Control Results Summary for Penicillin MTS Organism Concentration (µg/mL) Reference MTS S. pneumoniae ATCC 49619 Expected Result: 0.25-1 µg/mL 0.12 0 0 0.25 14 16 0.5 61 64 1 1 1 2 0 0 Inoculum Density Check: The inoculum was prepared to achieve turbidity equivalent to a 0.5 McFarland standard. Colony counts were performed periodically at each site for all QC replicates, from one replicate of each reproducibility isolate on each of the three days of testing, and from a minimum of 10% of the clinical and challenge strains tested. Inoculum density checks were performed, and the colony counts obtained for each isolate were within the recommended range of approximately 1x 108 CFU/mL. Purity Checks. Purity checks were performed on all isolates following MTS inoculation. Only results from pure cultures were evaluated. Growth Rate: The growth rate for the Liofilchem MIC Test Strip (MTS) with Penicillin was Regulation section:

idK181889_s2000_e4000

K181889.txt

proposed labeling

The labeling supports the finding of substantial equivalence for this device.

limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: The MTS, Penicillin was evaluated at three sites located within the United States. Each clinical isolate was tested one time by MTS, Penicillin and the reference method using the same initial standardized suspension. A total of 239 clinical fastidious Gram-positive isolates were tested which included 100 β-hemolytic Streptococcus spp. (60 S. pyogenes and 40 S. dysgalactiae), 48 Viridans Streptococcus spp. (23 S. 7 anginosus, 4 S. intermedius, and 21 S. constellatus), and 91 S. pneumoniae isolates. Of the clinical isolates, 54% were contemporary isolates tested within 6 months of isolation. All clinical isolates grew on the Mueller Hinton with 5% blood plate with the Penicillin MTS strip. Challenge testing was performed at one internal site. A total of 50 challenge fastidious Gram-positive isolates were tested which included 10 S. pyogenes, 15 Viridans Streptococcus spp. (7 S. anginosus, 2 S. constellatus, 6 S. intermedius), and 25 S. pneumoniae isolates. Results obtained with the Liofilchem MIC Test Strip (MTS), Penicillin were compared to results obtained with the CLSI broth microdilution reference panel. The same clinical and challenge isolates for S. pneumoniae were evaluated using both sets of interpretive criteria for meningitis and non-meningitis. The reference panel contained two-fold serial dilutions of penicillin with a range of 0.002 – 32 μg/mL. The testing conditions for the reference method were consistent with CLSI guidelines as listed in the CLSI document M07-A10. Isolated colonies from an overnight blood agar plate were suspended in saline to achieve a 0.5 McFarland standard turbidity (approximately 108 CFU/mL). Testing conditions consisted of incubation of the inoculated Mueller Hinton agar plates with 5% sheep blood in an inverted position at 35°C ± 2° for 20-24 hours. At the end of incubation, the MIC value at which the edge of the inhibition ellipse intersected the strip was compared to MIC results obtained with the reference method. The performance for the total 289 clinical and challenge isolates is summarized in Table 3 below. 8 Table 3: Performance of Clinical and Challenge Isolates (Combined) Penicillin EA Tot EA N EA % Eval. EA Tot Eval. EA N Eval. EA% CA N CA% #R min maj vmj β-hemolytic Streptococcus spp.1 Clinical 100 100 100 100 100 100 100 100 0 0 0 0 Challenge 10 10 100 10 10 100 10 100 0 0 0 0 Combined 110 110 100 110 110 100 110 100 0 0 0 0 Viridans Streptococcus spp.2 Clinical 48 45 93.8 46 44 95.7 48 100 0 0 0 0 Challenge 15 15 100 15 15 100 15 100 1 0 0 0 Combined 63 60 95.2 61 58 95.1 63 100 1 0 0 0 S. pneumoniae (non-meningitis breakpoints) Clinical 91 91 100 91 91 100 89 97.8 4 2 0 0 Challenge 25 25 100 24 24 100 21 84.0 5 4 0 0 Combined 116 116 100 115 115 100 110 94.8 9 6 0 0 S. pneumoniae (meningitis breakpoints) Clinical 91 91 100 91 91 100 89 97.8 43 N/A3 1 1 Challenge 25 25 100 24 24 100 25 100 24 N/A3 0 0 Combined 116 116 100 115 115 100 114 98.3 67 N/A3 1 1 1Includes S. pyogenes and S. dysgalactiae. 2Includes S. anginosus, S. intermedius, and S. constellatus. 3Not applicable due to lack of intermediate breakpoint. EA – Essential Agreement min – minor errors CA – Category Agreement maj – major errors EVAL – Evaluable isolates vmj – very major errors R – Resistant isolates Essential Agreement (EA) is when the Liofilchem MIC Test Strip (MST) results agree exactly or within one doubling dilution of the reference broth microdilution results. Category Agreement (CA) is when the Liofilchem MIC Test Strip (MST) result interpretation agrees exactly with the reference broth microdilution result interpretation. The overall performance for β-hemolytic Streptococcus spp. was acceptable with 100% EA and 100% CA. The overall performance for Viridans Streptococcus spp. was acceptable with 95.2% EA and 100% CA. When incorporating S. pneumoniae breakpoints for non-meningitis isolates, the overall performance was acceptable with 100% EA and 94.8% CA. There were six minor discrepancies, and no major or very major errors. When incorporating S. pneumoniae breakpoints for meningitis isolates, the overall performance was acceptable with 100% EA and 98.3% CA. There was one major error (0.5%), and one very major errors (1.5%). Both major and very major errors were acceptable. 9 Trending: Trending of ≥30% difference between higher and lower dilutions was observed (Table 4) for Penicillin MIC values against S. dysgalactiae and S. constellatus. For these organisms, MTS Penicillin MIC values tended to be in exact agreement or higher when compared to the reference method. The following footnote was included in the labeling to indicate this trending: “The MTS Penicillin MIC values tended to be in exact agreement or at least one doubling dilution higher when testing Streptococcus dysgalactiae and Streptococcus constellatus compared to the CLSI reference broth microdilution.” Table 4. Trending of Clinical and Challenge Results for Streptococcus spp. Total ≥2 dil. lower 1 dil. lower Exact 1 dil. higher ≥2 dil. higher S. pyogenesa 70 0 0 50 20 0 (0%) (71.43%) (28.57%) S. dysgalactiaeb 40 0 0 21 19 0 (0%) (52.50%) (47.50%) S. anginosusc 30 0 3 20 7 0 (10.00%) (66.67%) (23.33%) S. intermediusd 132 12 59 61 0 0 (53.79%) (46.21%) (0%) S. constellatuse 23 0 0 10 10 3 (0%) (43.48%) (56.52%) S. pneumoniae (meningitis)f 116 0 18 83 15 0 (15.52%) (71.55%) (12.93%) S. pneumoniae (non-meningitis)g 116 0 18 83 15 0 (15.52%) (71.55%) (12.93%) aDifference between the higher and lower dilutions for S. pyogenes is: 28.57%; 95% C.I. (17.96% to 40.05%) bDifference between the higher and lower dilutions for S. dysgalactiae is: 47.50%; 95% C.I. (30.50% to 62.50%) cDifference between the higher and lower dilutions for S. anginosus is: 13.33%; 95% C.I. (-6.09% to 32.1%) dDifference between the higher and lower dilutions for S. intermedius is: -22.22%; 95% C.I. (-54.77% to 16.53%) eDifference between the higher and lower dilutions for S. constellatus is: 56.52%; 95% C.I. (32.16% to 74.37%) fDifference between the higher and lower dilutions for S. pneumoniae (meningitis) is: -2.59%; 95% C.I. (- 11.72% to 6.55%) gDifference between the higher and lower dilutions for S. pneumoniae (non-meningitis) is: -2.59%; 95% C.I. (-11.72% to 6.55%) 10 b. Matrix comparison: Not Applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: The susceptibility interpretive criteria for Penicillin are as listed in Table 5. Table 5: Interpretive Criteria for Penicillin (µg/mL) Organism S I R β-hemolytic Streptococcus spp. ≤0.12 - - Viridans Group Streptococcus spp. ≤0.12 0.25-2 ≥4 S. pneumoniae meningitis ≤0.06 - ≥0.12 S. pneumoniae (non-meningitis) ≤2 4 ≥8 N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial Proposed labeling:

idK181379_s0_e2000

K181379.txt

purpose for submission

To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Purpose for submission:

idK181379_s0_e2000

K181379.txt

measurand

H. pylori antigen

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Measurand:

idK181379_s0_e2000

K181379.txt

type of test

Qualitative membrane enzyme immunoassay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Type of test:

idK181379_s0_e2000

K181379.txt

classification

Class I

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Classification:

idK181379_s0_e2000

K181379.txt

product code

LYR-– Campylobacter pylori

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Product code:

idK181379_s0_e2000

K181379.txt

panel

83-Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Panel:

idK181379_s0_e2000

K181379.txt

predicate device name

ImmunoCard STAT! HpSA

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Predicate device name:

idK181379_s0_e2000

K181379.txt

applicant

TechLab Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Applicant:

idK181379_s0_e2000

K181379.txt

proprietary and established names

H. PYLORI QUIK CHEK

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Proprietary and established names:

idK181379_s0_e2000

K181379.txt

regulation section

21 CFR 866.3110 Campylobacter fetus serological reagents

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181379 B. Purpose for Submission: To obtain a substantial equivalence determination for the detection of Helicobacter pylori antigens in human stool. C. Measurand: H. pylori antigen D. Type of Test: Qualitative membrane enzyme immunoassay E. Applicant: TechLab Inc. F. Proprietary and Established Names: H. PYLORI QUIK CHEK G. Regulatory Information: 1. Regulation section: 21 CFR 866.3110 Campylobacter fetus serological reagents 2. Classification: Class I 3. Product code: LYR-– Campylobacter pylori 4. Panel: 2 83-Microbiology H. Intended Use: 1. Intended use(s): The TECHLAB H. PYLORI QUIK CHEK test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. 2. Indication(s) for use: Same as the Intended Use. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The H. PYLORI QUIK CHEK test utilizes antibodies specific for H. pylori antigen in human fecal samples. The Membrane Device contains a “Reaction Window” with two vertical lines of immobilized antibodies. The test line (“T”) contains antibodies specific for H. pylori antigen. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The “Conjugate” consists of antibodies to H. pylori antigen coupled to horseradish peroxidase. After incubation, the Reaction Window is examined visually for the appearance of vertical blue lines on the “C” and “T” sides of the Reaction Window. A blue line on the “T” side of the Reaction Window indicates a positive result. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the Reaction Window, confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. It also confirms the reactivity of the other reagents associated with the assay. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ImmunoCard STAT! HpSA 2. Predicate 510(k) number(s): K032222 3. Comparison with predicate: Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Product Code LYR LYR Intended Use The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. . ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. Measured analyte Detection of H. pylori stool antigen Same 4 Similarities Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Target Population Persons suspected of having H. pylori infection Same Type of Test Qualitative Same Controls Positive and negative control included in kit Internal Control line Same Storage Refrigerated (2°C – 8°C) Same Reading Method Manual/Visual Same Differences Item Device: H. PYLORI QUIK CHEK (K181379) Predicate: ImmunoCard STAT! HpSA (K032222) Specimen Type Fecal Specimens in Cary-Blair and C&S Transport Media Unpreserved Fecal Specimen Time to Result 30 minutes 5 minutes Technology Enzyme Linked Immunoassay (ELISA) Immunochromatographic (ICT) Antibody Format Polyclonal/Polyclonal Monoclonal/Monoclonal K. Standard/Guidance Document Referenced (if applicable): CLSI EP07-A2 Interference Testing In Clinical Chemistry; Approved Guideline – Second Edition CLSI EP15-A3 User Verification of Precision And Estimation Of Bias; Approved Guideline - Third Edition CLSI EP17-A2 Evaluation Of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition L. Test Principle: Lateral flow immunochromatographic assay. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the H. PYLORI QUIK CHEK test was determined using an eight member masked fecal specimen panel. The panel consisted of 2 negative, 2 high negative (just below C5), 2 low positive (just above LoD), and 2 moderate positive (3-4x higher than the C95) specimens. Each fecal specimen was spiked using a known concentration of H. pylori purified flagellar antigen from whole organism to achieve the desired concentration. Testing was performed at 2 independent laboratories and on-site at TECHLAB, Inc. The Specimens were tested twice a day in triplicate over a five day period by multiple technicians at each site using two different kit lots. Positive and negative controls were run with each sample panel of masked specimens. The result from each laboratory were submitted to TECHLAB Inc. and compared. The results for the positive control, negative control, true negative, low positive, and moderate positive, was consistent among all three locations with100% reproducibility for all test panels. The high negative provided a positive result 63 out of 180 observations. b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Sample stability study: The effect of specimen storage on antigen stability was evaluated for both fresh stool samples and stool samples in transport media. The following transport media were used for the study: Thermo Scientific Protocol Cary Blair media and Thermo Scientific Protocol C&S media. For the analysis, a total of 32 fecal specimens were tested with the H. PYLORI QUIK CHEK test. The samples were prepared using a negative fecal matrix and spiked with H. pylori antigen (ATCC strain 43526). The panel consisted of 2 negative, 5 high negative (C5), 10 low positive (1-2x C95), and 15 positive specimens covering the range of the test (For fresh and preserved specimens this range was 50 ng/mL – 1200 ng/mL). Fresh samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 0, 24, 48,72 and 96 hours. Positive and negative controls were also tested at each timepoint. Fecal specimens added to Cary Blair and C&S media were transported as recommended in their respective package inserts; samples were stored at refrigerated temperatures (between 2ºC and 8ºC) and room temperatures (between 20ºC and 25ºC) and were tested at 24 hour intervals from 0 to 96 hours. 6 For fresh samples stored at refrigerated and room temperatures, the positive and negative samples gave the expected results 100% of the time. Storage in Cary Blair and C&S transport media did not affect the stability of the samples. Based on these results, the recommended storage time for fresh, Cary Blair, and C&S stored samples is up to 96 hours Regulation section:

idK181379_s4000_e6000

K181379.txt

proposed labeling

The labeling supports the finding of substantial equivalence for this device.

and specificity for the H. PYLORI QUIK CHEK test was determined using the CRM. Prospective testing consisted of 205 stool specimens collected from the patients with symptoms of dyspepsia, gastritis, or peptic ulcer who were scheduled to undergo endoscopy with gastric biopsy as part of routine care (Initial Diagnosis Group). Of these, 83 patients were excluded either because they were on a treatment regimen [i.e., proton-pump inhibitors (PPIs), or antibiotics] or had samples with CRM results that were rapid urease positive but histology negative. The remaining 122 patients who were not taking PPIs or antibiotics at the time of specimen collection were considered for final analysis. These specimens were tested at the following five sites: Carilion Clinic, International Centre for Diarrhoeal Disease Research Bangladesh, Mayo Clinic, University of Virginia, Kliniken Essen-Mitte, and TECHLAB (internal). 10 The ages of patients ranged from less than 19 years to 82 years with 100% of the specimens coming from patients were > 18 years. Of the 122 patients tested 64% were female and 34% were male. No difference in test performance was observed based on patient age or gender. The results are provided in Table 3 which shows the clinical performance of the H. PYLORI QUIK CHEK test for all 6 test sites combined. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a sensitivity of 97.0%, and a specificity of 100% compared to the CRM. Table 3. Clinical Performance of the H. PYLORI QUIK CHEK Initial diagnosis CRM Positive CRM Negative H. PYLORI QUIK CHEK Positive 32 0 H. PYLORI QUIK CHEK Negative 1* 89 Sensitivity (95% C.I.) 97.0% (84.7% - 99.5%) Specificity (95% C.I.) 100%(95.9% - 100%) *Additional testing with an FDA cleared H. pylori stool antigen test provided an antigen negative result. Post Therapy Diagnosis Eradication (post-therapy) evaluation was conducted on patients enrolled prospectively at 3 sites. A total of 9 specimens were collected at least 4 weeks after completion of the treatment regimen. Post therapy evaluation was conducted using a two-step algorithm of patient analysis. First, patients were screened for the continued presence of H. pylori using an FDA-cleared stool antigen test. Positive patients were reflexed to a follow-up endoscopy and biopsy analysis by rapid urease test and histology. The results are provided in Table 4 which shows the clinical performance of the H. PYLORI QUIK CHEK test for all 6 test sites combined. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a sensitivity of 100.0% compared to the CRM. Table 4. Clinical Performance of the H. PYLORI QUIK CHEK Post treatment diagnosis CRM Positive CRM Negative H. PYLORI QUIK CHEK Positive 9 0 H. PYLORI QUIK CHEK Negative 0 0 Sensitivity (95% C.I.) 100% (70.1% - 100%) The ages of patients ranged from 33 years to 72 Years. Of the 9 patients tested, 6 11 were female and 3 were male. Retrospective study A retrospective study was conducted to evaluate performance and to augment the prospective clinical study. Testing of retrospective samples was conducted at TECHLAB. To provide assurance that the retrospective samples are representative of wide range of OD readings, CRM positives samples and retrospective positive samples were both tested by an FDA cleared ELISA. The distribution and mean OD values obtained from the retrospective study, n = 200 samples, were compared to those values obtained from CRM positive samples, n = 46, to ensure that the use of retrospective sample results reflects the OD distribution of CRM positive samples. This analysis demonstrated that the use of retrospective and prospective clinical samples has similar distributions and no concern of bias was noted. The performance of the H. PYLORI QUIK CHEK test was evaluated by testing retrospective samples at TECHLAB. Retrospective testing consisted of 200 frozen stool specimens (94 positive and 106 negative by an FDA Cleared ELISA) obtained from sample repositories. Positive percent agreement (PPA) and negative percent agreement (NPA) for the H. PYLORI QUIK CHEK test was determined by comparing to an FDA Cleared ELISA that was tested concurrently. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a PPA of 98.9% and a NPA of 97.2% with an FDA Cleared ELISA. The results are shown in Table 5. Table 5. Clinical performance of the H. PYLORI QUIK CHEK test on retrospective specimens. N = 200 FDA Cleared ELISA (Positive) FDA Cleared ELISA (Negative) H. PYLORI QUIK CHEK Positive 93 3** H. PYLORI QUIK CHEK Negative 1* 103 Performance 95% CI Positive Percent Agreement 98.9% 94.2%-99.8% Negative Percent Agreement 97.2% 92.0%-99.0% * H. pylori DNA was amplified from the samples with PCR **No H. pylori DNA was amplified from the sample with PCR 12 b. Clinical specificity: See section M3a. above. c. Other clinical supportive data (when a. and b. are not applicable): See section M3a. above. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK181379_s4000_e6000

K181379.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

The sensitivity and specificity for the H. PYLORI QUIK CHEK test was determined using the CRM. Prospective testing consisted of 205 stool specimens collected from the patients with symptoms of dyspepsia, gastritis, or peptic ulcer who were scheduled to undergo endoscopy with gastric biopsy as part of routine care (Initial Diagnosis Group). Of these, 83 patients were excluded either because they were on a treatment regimen [i.e., proton-pump inhibitors (PPIs), or antibiotics] or had samples with CRM results that were rapid urease positive but histology negative. The remaining 122 patients who were not taking PPIs or antibiotics at the time of specimen collection were considered for final analysis. These specimens were tested at the following five sites: Carilion Clinic, International Centre for Diarrhoeal Disease Research Bangladesh, Mayo Clinic, University of Virginia, Kliniken Essen-Mitte, and TECHLAB (internal). 10 The ages of patients ranged from less than 19 years to 82 years with 100% of the specimens coming from patients were > 18 years. Of the 122 patients tested 64% were female and 34% were male. No difference in test performance was observed based on patient age or gender. The results are provided in Table 3 which shows the clinical performance of the H. PYLORI QUIK CHEK test for all 6 test sites combined. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a sensitivity of 97.0%, and a specificity of 100% compared to the CRM. Table 3. Clinical Performance of the H. PYLORI QUIK CHEK Initial diagnosis CRM Positive CRM Negative H. PYLORI QUIK CHEK Positive 32 0 H. PYLORI QUIK CHEK Negative 1* 89 Sensitivity (95% C.I.) 97.0% (84.7% - 99.5%) Specificity (95% C.I.) 100%(95.9% - 100%) *Additional testing with an FDA cleared H. pylori stool antigen test provided an antigen negative result. Post Therapy Diagnosis Eradication (post-therapy) evaluation was conducted on patients enrolled prospectively at 3 sites. A total of 9 specimens were collected at least 4 weeks after completion of the treatment regimen. Post therapy evaluation was conducted using a two-step algorithm of patient analysis. First, patients were screened for the continued presence of H. pylori using an FDA-cleared stool antigen test. Positive patients were reflexed to a follow-up endoscopy and biopsy analysis by rapid urease test and histology. The results are provided in Table 4 which shows the clinical performance of the H. PYLORI QUIK CHEK test for all 6 test sites combined. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a sensitivity of 100.0% compared to the CRM. Table 4. Clinical Performance of the H. PYLORI QUIK CHEK Post treatment diagnosis CRM Positive CRM Negative H. PYLORI QUIK CHEK Positive 9 0 H. PYLORI QUIK CHEK Negative 0 0 Sensitivity (95% C.I.) 100% (70.1% - 100%) The ages of patients ranged from 33 years to 72 Years. Of the 9 patients tested, 6 11 were female and 3 were male. Retrospective study A retrospective study was conducted to evaluate performance and to augment the prospective clinical study. Testing of retrospective samples was conducted at TECHLAB. To provide assurance that the retrospective samples are representative of wide range of OD readings, CRM positives samples and retrospective positive samples were both tested by an FDA cleared ELISA. The distribution and mean OD values obtained from the retrospective study, n = 200 samples, were compared to those values obtained from CRM positive samples, n = 46, to ensure that the use of retrospective sample results reflects the OD distribution of CRM positive samples. This analysis demonstrated that the use of retrospective and prospective clinical samples has similar distributions and no concern of bias was noted. The performance of the H. PYLORI QUIK CHEK test was evaluated by testing retrospective samples at TECHLAB. Retrospective testing consisted of 200 frozen stool specimens (94 positive and 106 negative by an FDA Cleared ELISA) obtained from sample repositories. Positive percent agreement (PPA) and negative percent agreement (NPA) for the H. PYLORI QUIK CHEK test was determined by comparing to an FDA Cleared ELISA that was tested concurrently. The results of the study show that the H. PYLORI QUIK CHEK test exhibited a PPA of 98.9% and a NPA of 97.2% with an FDA Cleared ELISA. The results are shown in Table 5. Table 5. Clinical performance of the H. PYLORI QUIK CHEK test on retrospective specimens. N = 200 FDA Cleared ELISA (Positive) FDA Cleared ELISA (Negative) H. PYLORI QUIK CHEK Positive 93 3** H. PYLORI QUIK CHEK Negative 1* 103 Performance 95% CI Positive Percent Agreement 98.9% 94.2%-99.8% Negative Percent Agreement 97.2% 92.0%-99.0% * H. pylori DNA was amplified from the samples with PCR **No H. pylori DNA was amplified from the sample with PCR 12 b. Clinical specificity: See section M3a. above. c. Other clinical supportive data (when a. and b. are not applicable): See section M3a. above. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK162333_s0_e2000

K162333.txt

purpose for submission

Clearance of a new device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Purpose for submission:

idK162333_s0_e2000

K162333.txt

measurand

Human hemoglobin (hHb) in feces

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Measurand:

idK162333_s0_e2000

K162333.txt

type of test

Lateral flow chromatographic immunoassay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Type of test:

idK162333_s0_e2000

K162333.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Classification:

idK162333_s0_e2000

K162333.txt

product code

KHE, Reagent, Occult Blood

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Product code:

idK162333_s0_e2000

K162333.txt

panel

Hematology (81)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Panel:

idK162333_s0_e2000

K162333.txt

indications for use

Same as Intended Use

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Indications for use:

idK162333_s0_e2000

K162333.txt

predicate device name

FOB One Step Rapid Test (Orient Gene Biotech)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Predicate device name:

idK162333_s0_e2000

K162333.txt

applicant

Guangzhou Wondfo Biotech Co., Ltd.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Applicant:

idK162333_s0_e2000

K162333.txt

proprietary and established names

Wondfo One Step Fecal Occult Blood Test

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Proprietary and established names:

idK162333_s0_e2000

K162333.txt

regulation section

21 CFR 864.6550, Occult blood test

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162333 B. Purpose for Submission: Clearance of a new device C. Measurand: Human hemoglobin (hHb) in feces D. Type of Test: Lateral flow chromatographic immunoassay E. Applicant: Guangzhou Wondfo Biotech Co., Ltd. F. Proprietary and Established Names: Wondfo One Step Fecal Occult Blood Test G. Regulatory Information: 1. Regulation section: 21 CFR 864.6550, Occult blood test 2. Classification: Class II 3. Product code: KHE, Reagent, Occult Blood 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription and over-the-counter (OTC) use. 4. Special instrument requirements: Not applicable I. Device Description: The Wondfo One Step Fecal Occult Blood (FOB) Test kit consists of the following components: a. Test cassette individually wrapped in a single pouch b. Collection tubes with 1.5 mL extraction buffer solution c. Clean collection papers d. Instructions for use J. Substantial Equivalence Information: 1. Predicate device name(s): FOB One Step Rapid Test (Orient Gene Biotech) 2. Predicate 510(k) number(s): K110309 3. Comparison with predicate: 3 Similarities Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Intended/Indications for Use Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal (GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use. The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. Specimen Type Human feces (mixed with detection buffer) Same Test Principle Lateral flow chromatographic immunoassay Same Differences Item Device Wondfo One Step Fecal Occult Blood Test, K162333 Predicate Orient Gene Biotech One Step Rapid FOB Test, K110309 Assay Cut-off 45 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) 50 ng/mL (Human hemoglobin in human fecal sample mixed with detection buffer) Results Interpretation Time Read the test results after 10 minutes. Some positive results may be seen earlier. Do not read results after 30 minutes. Read test results between 5-10 minutes. Test results read earlier than 5 minutes and later than 10 minutes are not valid. Storage 4–30°C 2–30°C K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Wondfo One Step Fecal Occult Blood Test is a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. When the extracted specimen (~33mg/mL) is introduced to the sample well of the testing cassette, the specimen is absorbed into the device by capillary action, mixes with the hemoglobin specific mouse monoclonal antibody-dye conjugate, and flows across the pre-coated membrane. The bound complexes (antibody-dye conjugates/hHb) are then captured by antibodies immobilized 4 in the test region (T) of the device. When the hemoglobin antigen levels in specimens are at or above the target cut-off, the immobilized antibody-dye conjugate/antigen complex produces a colored test band and indicates a positive result. When the hemoglobin antigen levels in specimens are below the target cut-off, there is no visible colored band in the test region (T) of the device, indicating a negative result. To serve as a procedural control, a colored line will appear at the control region (C), if the test has been performed properly. M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: Repeatability was evaluated using a single test kit lot and one operator; whereas reproducibility was conducted across three point-of-care (POC) sites in the U.S. using three test kit lots (one lot per site), three operators per site, performing one run per day for five non-consecutive days. For repeatability and reproducibility, Hb-free fecal samples were collected and spiked with hemoglobin to achieve the following seven fecal hemoglobin concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0 ng/mL, 40 ng/mL, 45 ng/mL, 50 ng/mL, 60 ng/mL, 75 ng/mL and 2000 ng/mL, respectively. Twenty-one replicates were performed for each sample and concentration level. Repeatability and reproducibility results at all test sites passed acceptance criteria. Table 1. Precision Performance Type of Precision Study Actual Results Expected Results Overall Percent Agreement Positive Percent Agreement (95% CI) Negative Percent Agreement (95% CI) Wondfo One Step (FOB) Test Positive Results Negative Results Total Results Repeatability Positive Results 95 1 96 99.3% 100.0% (96.2% – 100.0%) 98.1% (89.9% – 99.7%) Negative Results 0 51 51 Total Results 95 52 147 Lot-to-Lot Reproducibility Positive Results 471 2 473 99.2% 99.2% (97.8% – 99.7%) 99.2% (97.2% – 99.8%) Negative Results 4 258 262 Total Results 475 260 735 Between-run Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Between-Device Reproducibility Positive Results 472 2 474 99.3% 99.4% (98.2% – 99.8%) 99.2% (97.2% – 98.8%) Negative Results 3 258 261 Total Results 475 260 735 Between-site Reproducibility Positive Results 471 4 475 98.9% 99.2% (97.8% – 99.7%) 98.5% (96.1% – 99.4%) Negative Results 4 256 260 Total Results 475 260 735 Combined Reproducibility Positive Results 1414 8 1422 99.1% 99.2% (98.6% – 99.6%) 99.0% (98.0% – 99.5%) Negative Results 11 772 783 Total Results 1425 780 2205 5 b. Linearity/assay reportable range: Prozone (Hook Effect) Susceptibility of the Wondfo One Step Fecal Occult Blood (FOB) Test to prozone effects was evaluated using three test kit lots and three operators. Hemoglobin-free stool specimens were collected and spiked with human blood of known hemoglobin concentrations to obtain the following concentrations: 60000 μg Hb/g stool, 6000 μg Hb/g stool, 600 μg Hb/g stool, 60 μg Hb/g stool, 30 μg Hb/g stool, 15 μg Hb/g stool and 7.5 μg Hb/g stool. These concentrations are equivalent to the following hemoglobin concentrations when diluted with extraction buffer: 2 mg/mL, 200 μg/mL, 20 μg/mL, 2 μg/mL, 1 μg /mL, 500 ng/mL and 250 ng/mL respectively. Five aliquots of each sample mixed with extraction buffer in the specimen collection tubes were prepared and tested in a randomized order. It was determined that the Wondfo One Step Fecal Occult Blood (FOB) Test is not susceptible to prozone/hook effect up to a hemoglobin concentration of 200 μg/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Internal Control Procedural controls are included in the test device. A rose/pink line in the control region is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. External Controls It is recommended that Regulation section:

idK162333_s6000_e8000

K162333.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

Test Positive Negative Total POC Site 1 Positive 35 0 35 100% 100% (90.1%-100%) 100% (96.3%-100%) Negative 0 101 101 Total 35 101 136 POC Site 2 Positive 45 0 45 99.3% 97.8% (88.7%-99.6%) 100% (96.3%-100%) Negative 1 101 102 Total 46 101 147 POC Site 3 Positive 52 1 53 99.6% 100% (93.1%-100%) 99.5% (7.1%-99.9%) Negative 0 189 189 Total 52 190 242 Combined Sites Positive 132 1 133 99.6% 99.2% (95.9%-99.9%) 99.7% (98.6%-100%) Negative 1 391 392 Total 133 392 525 Lay User Study To support over the counter use, a lay user study (Tables 4, 5) was performed at three intended user sites with 100 lay users testing his/her own stool sample using the device according to the package insert. The lay users also provided a sample for professional testing. The overall agreement between the results obtained by lay-users and professional users was 100%. The lay users also tested spiked samples. Human Negative stool samples in collection buffer tubes (50mg feces in 1.5mL FOB buffer solution) were spiked with hemoglobin at concentrations of 0, 37.5, 50, 62.5, and 2000 ng/ml. A total of twenty spiked samples were made at each concentration. Each lay user tested only one spiked sample. All results are compared with that obtained by professionals. Two discrepant results were found for two samples near the cutoff at 37.5ng/mL concentration. The overall agreement between the results obtained by lay- users and professional users was 98%. Table 4. Lay users testing their own specimens Professional Test Results Total Results Lay User Test Results Results Positive Negative Positive 12 0 12 Negative 0 88 88 Total Results 12 88 100 12 Table 5. Lay user testing spiked specimens Hemoglobin Concentration (ng/mL) Number of Samples Lay User Results Professional Results Percent Negative Agreement Percent Positive Agreement Negative Positive Negative Positive 0 20 20 0 20 0 100% N/A 37.5 20 18 2 20 0 90% N/A 50 20 0 20 0 20 N/A 100% 62.5 20 0 20 0 20 N/A 100% 2000 20 0 20 0 20 N/A 100% b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Instrument Name: Not applicable O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? 13 Yes ________ or No ___x_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ________ or No __X_____ 3. Specimen Identification: Enter patient identification information manually on the label of the Sampling Collection Tube. 4. Specimen Sampling and Handling: If testing is performed by a laboratory, it is recommended that the laboratory should give the Wondfo One Step Fecal Occult Blood (FOB) Test sample collection tube to the patient for fecal sample collection. The patient should submit the sample to the laboratory for testing as per the appropriate instructions received from the laboratory. The sample must be returned or mailed to the doctor/laboratory within 48 hours of sampling. Testing may also be performed by the consumer if purchased over-the-counter. The sample can be stored at room temperature for up to 15 days or can be refrigerated at 2–8°C (36–46°F) for up to 30 days. For long term storage, specimens should be kept at -20°C (-4°F). 5. Calibration: Not applicable 6. Quality Control: Internal Control: The Procedural Control is found in the procedural control region of the test cassette to assure the operator that the test has been properly performed. This control does not ensure that the capture antibody is accurately detecting the presence or absence of Hb in the sample. External control: External controls are used to assure the operator that the capture and conjugated antibodies are present and reactive. Controls should be assayed according to the manufacturer’s instructions once per kit lot, following the local and state guidelines. If controls do not perform as expected, the test results should not be used. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1. Test Kit Reaction Time: 14 The Wondfo One Step Fecal Occult Blood (FOB) Test reaction time was demonstrated by using seven stool concentrations at eight different time points. Reaction time test samples were prepared by spiking Hb-free stool specimen with known levels of human Hb solution to obtain fecal samples with seven different Hb concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0, 40, 45, 50, 60, 75 and 2000 ng/mL, respectively. Twenty one replicates of each sample were collected with Wondfo One Step Fecal Occult Blood (FOB) Test sample collection tubes. All specimens were tested with one test kit lot in a randomized and blinded manner by one operator. The test results were read and recorded at 3, 5, 8, 10, 20, 30, 40 and 60 minutes. Positivity rate of 0 ng/mL was 0%, positivity rate of 40 ng/mL was 4.8%, positivity rate of 45 ng/mL was 47.6%, and the positivity rate of 50 ng/mL was 100% at 10 minutes of reaction. The appropriate reaction time of Wondfo One Step Fecal Occult Blood (FOB) Test was demonstrated as 10 minutes. 2. Operator Intensity Reading: The operator intensity reading test was performed by utilizing test samples prepared by spiking Hb-free stool specimen with known levels of human Hb solution to obtain fecal samples with seven different Hb concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0, 40 , 45, 50, 60, 75 and 2000 ng/mL, respectively. Twenty-five replicates were prepared for each concentration. All specimens were tested with one test kit lot in a randomized and blinded manner by five different readers at one intended use site. The study participants recorded the results and graded the intensity of the test line from 10 levels: (B (no test line), C9 (faint test line), C8, C7, C6, C5, C4, C3, C2 and C1 (deepest test line). The intensity of the test line increased in correlation with the Hb concentration of stool test samples. There was no statistical significance in the analyses of the test samples performed by the operators for the intensity reading test study. 3. Specimen Collection Verification: Verification that the applicator device for the Wondfo One Step Fecal Occult Blood (FOB) Test consistently delivers the specified amount of stool required for optimal test performance was performed by five lay users using five positive and five negative clinical samples per lay user. The study was performed at one intended use site. Five positive and 5 negative clinical samples results were confirmed using the predicate device and the proposed device. A professional operator used an electronic balance and weighed the sampling stick first so that this weight could be offset. The lay users then inserted the sampling stick into test stool sample at six different sites to collect samples and placed the sampling stick back in to the sample collection tube (without buffer). After, the professional operator used the electronic balance to weigh the sample stick with stool sample. The lay users next used three sample collection tubes (with buffer) to collect the sample again and used three test cassettes of Wondfo One Step Fecal Occult Blood (FOB) Test to test the result according to the test procedure directions of the package insert. The average value for sample volume collected was 0.0517g and the standard deviation was 0.0027, 15 which demonstrated the consistency of the sampling. The total positive and negative results obtained by the lay users are consistent with the expected results for the test samples. The lay users collected adequate consistent amounts of stool samples when following the package insert directions to perform the Wondfo One Step Fecal Occult Blood (FOB) Test. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK162333_s6000_e8000

K162333.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Step Rapid Test Positive Negative Total POC Site 1 Positive 35 0 35 100% 100% (90.1%-100%) 100% (96.3%-100%) Negative 0 101 101 Total 35 101 136 POC Site 2 Positive 45 0 45 99.3% 97.8% (88.7%-99.6%) 100% (96.3%-100%) Negative 1 101 102 Total 46 101 147 POC Site 3 Positive 52 1 53 99.6% 100% (93.1%-100%) 99.5% (7.1%-99.9%) Negative 0 189 189 Total 52 190 242 Combined Sites Positive 132 1 133 99.6% 99.2% (95.9%-99.9%) 99.7% (98.6%-100%) Negative 1 391 392 Total 133 392 525 Lay User Study To support over the counter use, a lay user study (Tables 4, 5) was performed at three intended user sites with 100 lay users testing his/her own stool sample using the device according to the package insert. The lay users also provided a sample for professional testing. The overall agreement between the results obtained by lay-users and professional users was 100%. The lay users also tested spiked samples. Human Negative stool samples in collection buffer tubes (50mg feces in 1.5mL FOB buffer solution) were spiked with hemoglobin at concentrations of 0, 37.5, 50, 62.5, and 2000 ng/ml. A total of twenty spiked samples were made at each concentration. Each lay user tested only one spiked sample. All results are compared with that obtained by professionals. Two discrepant results were found for two samples near the cutoff at 37.5ng/mL concentration. The overall agreement between the results obtained by lay- users and professional users was 98%. Table 4. Lay users testing their own specimens Professional Test Results Total Results Lay User Test Results Results Positive Negative Positive 12 0 12 Negative 0 88 88 Total Results 12 88 100 12 Table 5. Lay user testing spiked specimens Hemoglobin Concentration (ng/mL) Number of Samples Lay User Results Professional Results Percent Negative Agreement Percent Positive Agreement Negative Positive Negative Positive 0 20 20 0 20 0 100% N/A 37.5 20 18 2 20 0 90% N/A 50 20 0 20 0 20 N/A 100% 62.5 20 0 20 0 20 N/A 100% 2000 20 0 20 0 20 N/A 100% b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Instrument Name: Not applicable O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? 13 Yes ________ or No ___x_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ________ or No __X_____ 3. Specimen Identification: Enter patient identification information manually on the label of the Sampling Collection Tube. 4. Specimen Sampling and Handling: If testing is performed by a laboratory, it is recommended that the laboratory should give the Wondfo One Step Fecal Occult Blood (FOB) Test sample collection tube to the patient for fecal sample collection. The patient should submit the sample to the laboratory for testing as per the appropriate instructions received from the laboratory. The sample must be returned or mailed to the doctor/laboratory within 48 hours of sampling. Testing may also be performed by the consumer if purchased over-the-counter. The sample can be stored at room temperature for up to 15 days or can be refrigerated at 2–8°C (36–46°F) for up to 30 days. For long term storage, specimens should be kept at -20°C (-4°F). 5. Calibration: Not applicable 6. Quality Control: Internal Control: The Procedural Control is found in the procedural control region of the test cassette to assure the operator that the test has been properly performed. This control does not ensure that the capture antibody is accurately detecting the presence or absence of Hb in the sample. External control: External controls are used to assure the operator that the capture and conjugated antibodies are present and reactive. Controls should be assayed according to the manufacturer’s instructions once per kit lot, following the local and state guidelines. If controls do not perform as expected, the test results should not be used. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1. Test Kit Reaction Time: 14 The Wondfo One Step Fecal Occult Blood (FOB) Test reaction time was demonstrated by using seven stool concentrations at eight different time points. Reaction time test samples were prepared by spiking Hb-free stool specimen with known levels of human Hb solution to obtain fecal samples with seven different Hb concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0, 40, 45, 50, 60, 75 and 2000 ng/mL, respectively. Twenty one replicates of each sample were collected with Wondfo One Step Fecal Occult Blood (FOB) Test sample collection tubes. All specimens were tested with one test kit lot in a randomized and blinded manner by one operator. The test results were read and recorded at 3, 5, 8, 10, 20, 30, 40 and 60 minutes. Positivity rate of 0 ng/mL was 0%, positivity rate of 40 ng/mL was 4.8%, positivity rate of 45 ng/mL was 47.6%, and the positivity rate of 50 ng/mL was 100% at 10 minutes of reaction. The appropriate reaction time of Wondfo One Step Fecal Occult Blood (FOB) Test was demonstrated as 10 minutes. 2. Operator Intensity Reading: The operator intensity reading test was performed by utilizing test samples prepared by spiking Hb-free stool specimen with known levels of human Hb solution to obtain fecal samples with seven different Hb concentrations: 0 μg Hb/g stool, 1.2 μg Hb/g stool, 1.35 μg Hb/g stool, 1.5 μg Hb/g stool, 1.8 μg Hb/g stool, 2.25 μg Hb/g stool, and 60 μg Hb/g stool, that are equivalent to 0, 40 , 45, 50, 60, 75 and 2000 ng/mL, respectively. Twenty-five replicates were prepared for each concentration. All specimens were tested with one test kit lot in a randomized and blinded manner by five different readers at one intended use site. The study participants recorded the results and graded the intensity of the test line from 10 levels: (B (no test line), C9 (faint test line), C8, C7, C6, C5, C4, C3, C2 and C1 (deepest test line). The intensity of the test line increased in correlation with the Hb concentration of stool test samples. There was no statistical significance in the analyses of the test samples performed by the operators for the intensity reading test study. 3. Specimen Collection Verification: Verification that the applicator device for the Wondfo One Step Fecal Occult Blood (FOB) Test consistently delivers the specified amount of stool required for optimal test performance was performed by five lay users using five positive and five negative clinical samples per lay user. The study was performed at one intended use site. Five positive and 5 negative clinical samples results were confirmed using the predicate device and the proposed device. A professional operator used an electronic balance and weighed the sampling stick first so that this weight could be offset. The lay users then inserted the sampling stick into test stool sample at six different sites to collect samples and placed the sampling stick back in to the sample collection tube (without buffer). After, the professional operator used the electronic balance to weigh the sample stick with stool sample. The lay users next used three sample collection tubes (with buffer) to collect the sample again and used three test cassettes of Wondfo One Step Fecal Occult Blood (FOB) Test to test the result according to the test procedure directions of the package insert. The average value for sample volume collected was 0.0517g and the standard deviation was 0.0027, 15 which demonstrated the consistency of the sampling. The total positive and negative results obtained by the lay users are consistent with the expected results for the test samples. The lay users collected adequate consistent amounts of stool samples when following the package insert directions to perform the Wondfo One Step Fecal Occult Blood (FOB) Test. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK181700_s0_e2000

K181700.txt

purpose for submission

Addition of Plazomicin Antimicrobial Susceptibility Test Disk

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Purpose for submission:

idK181700_s0_e2000

K181700.txt

measurand

Plazomicin 30µg

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Measurand:

idK181700_s0_e2000

K181700.txt

type of test

Antimicrobial Susceptibility Test Disks

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Type of test:

idK181700_s0_e2000

K181700.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Classification:

idK181700_s0_e2000

K181700.txt

product code

JTN

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Product code:

idK181700_s0_e2000

K181700.txt

panel

83, Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Panel:

idK181700_s0_e2000

K181700.txt

intended use

HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Intended use:

idK181700_s0_e2000

K181700.txt

predicate device name

HardyDisk Tigecycline 15µg

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Predicate device name:

idK181700_s0_e2000

K181700.txt

applicant

Hardy Diagnostics

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Applicant:

idK181700_s0_e2000

K181700.txt

proprietary and established names

HardyDisk AST Plazomicin 30µg (PLZ30)

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Proprietary and established names:

idK181700_s0_e2000

K181700.txt

regulation section

21 CFR 866.1620 Antimicrobial Susceptibility Test Disc

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181700 B. Purpose for Submission: Addition of Plazomicin Antimicrobial Susceptibility Test Disk C. Measurand: Plazomicin 30µg D. Type of Test: Antimicrobial Susceptibility Test Disks E. Applicant: Hardy Diagnostics F. Proprietary and Established Names: HardyDisk AST Plazomicin 30µg (PLZ30) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1620 Antimicrobial Susceptibility Test Disc 2. Classification: Class II 3. Product code: JTN 4. Panel: 83, Microbiology 2 H. Intended Use: 1. Intended use(s): HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 2. Indication(s) for use: Use of HardyDisk AST Plazomicin 30µg (PLZ30) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Plazomicin. Plazomicin has been shown to be active against susceptible isolates of the following bacteria both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter cloacae Plazomicin has been shown to be active in vitro against susceptible isolates of the following bacteria: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcenscens HardyDisk AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. 3 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: N/A I. Device Description: HardyDisk AST Disks utilize 6-mm diameter white filter paper disks. The disks are prepared by impregnating absorbent paper with a known concentration of 30µg Plazomicin. The disks are marked with the code PLZ30 on both sides. HardyDisk AST Disks are supplied in plastic cartridges containing 50 disks each. They are also packaged as one cartridge per vial with desiccant or five cartridges per vial with desiccant. J. Substantial Equivalence Information: 1. Predicate device name(s): HardyDisk Tigecycline 15µg 2. Predicate 510(k) number(s): K062245 3. Comparison with predicate: 4 Table 1: Comparison with the Predicate Similarities Item Device K181700 HardyDisk Plazomicin 30µg Predicate K062245 HardyDisk Tigecycline 15µg Test Method Antimicrobial Susceptibility Testing using paper disks impregnated with an antimicrobial agent Same Methodology Kirby-Bauer Disk Diffusion Susceptibility Test Protocol requires the user to determine categorical interpretations (S/I/R) using the measured zone diameters. Same Inoculum Prepared from pure isolated colonies to match the turbidity equivalent of a 0.5 McFarland in Tryptic Soy Broth. Same Inoculation Method Dip a sterile swab into the prepared inoculum and streak an appropriate agar plate’s surface three times. Add the disks impregnated with the antimicrobial agent to the surface of the plate. Incubate the agar plate agar side up in a 35 ± 2°C incubator for 16- 18 hours. Same Reading Method The user will interpret the zone diameters according established interpretive criteria for the drug. Same Differences Item Device Predicate Product Name HardyDisk Plazomicin 30µg (PLZ30) HardyDisk Tigecycline Antimicrobial Agent Plazomicin Tigecycline Concentration 30µg 15µg K. Standard/Guidance Document Referenced (if applicable): CLSI M100 28th Edition, Performance Standards for Antimicrobial Susceptibility Testing L. Test Principle: The HardyDisk AST Disk is based on the agar diffusion (Kirby-Bauer) methodology. It utilizes dried filter paper disks impregnated with a known concentration of an antimicrobial agent that are placed onto the test medium surface. Mueller Hinton agar is recommended for agar diffusion testing of non-fastidious organisms and Mueller Hinton with 5% Sheep Blood 5 is recommended for Streptococcus spp. Three to five similar colonies are transferred to 4-5 mL of a suitable broth medium. The broth is incubated at 35°C for 2-6 hours to develop a turbidity that exceeds or is equivalent to a 0.5 McFarland standard. Alternatively, a direct broth or saline suspension of colonies may be prepared from an overnight culture. The final inoculum density should be equivalent to a 0.5 McFarland turbidity standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller Hinton agar plate is streaked with an inoculated swab to obtain an even inoculation of organism. Disks are aseptically placed onto the agar surface with a disk dispenser and the disks are pressed down with a sterile needle or forceps to make contact with the agar surface. Agar plates are incubated in an ambient air incubator at 35±2°C for 16 - 18 hours. Fastidious organisms are tested using appropriate media incubated in an atmosphere enriched with 5% CO2, as recommended in the CLSI M02 approved standard document. After incubation the agar medium is examined for a zone of inhibition around the disks. The zones of inhibition are measured to the nearest millimeter and compared to recognized zone size ranges for the antimicrobial agent being tested. M. Performance Characteristics (if/when applicable): Descriptive characteristics were sufficient for the HardyDisk Plazomicin 30µg (PLZ30) disk based on extensive data from several microbiology disk studies evaluated by CDER which were used to generate the breakpoints and quality control (QC) expected ranges used for this subject device. The disk data used to support this submission included data from testing organisms within the spectrum of activity of plazomicin. Data was obtained from reproducibility, quality control and disk to MIC correlation studies and was generated in accordance with the CDER Clinical/Antimicrobial guidance, Microbiology Data for Systemic Antibacterial Drugs- Development, Analysis, and Presentation to ensure precise, accurate, and reproducible results. For this review, the interpretative criteria are applied broadly to include the Enterobacteriaceae family. The list of bacterial species has been expanded and is not limited only to the indicated species. The following statements are added as footnotes to the plazomicin interpretative criteria table for Enterobacteriaceae in the HardyDisk AST package insert: The statement below is added to the package insert and is consistent with the FDA STIC website: o The safety and efficacy of plazomicin in treating clinical infections due to organisms other than Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae may not have been established in adequate and well- controlled clinical trials. The clinical significance of susceptibility information in such instances is unknown. 6 Regarding resistance marker/enzyme characterization, Enterobacteriaceae isolates harboring extended spectrum βeta-Lactamases (ESBL) including CTX-M, SHV, TEM; AmpC; carbapenemases (KPC, NDM, OXA, VIM); aminoglycoside modifying enzymes (AMEs) including AAC, AAD, ANT, APH; 16S rRNA methyltransferases (plazomicin resistant RMTB and armA) were tested with the HardyDisk Plazomicin. Information regarding the performance of Plazomicin with isolates that exhibit overexpression of efflux pumps or lower expression of porins is provided in the following footnote: o The performance of HardyDisk AST Plazomicin 30μg (PLZ30) is unknown for Enterobacteriaceae with the following Regulation section:

idK181700_s2000_e4000

K181700.txt

proposed labeling

The labeling supports the finding of substantial equivalence for this device.

ression of efflux pumps (e.g., acrAB-tolC) or lower expression of porins (e.g., ompF or ompK36). 1. Analytical performance: a. Precision/Reproducibility: Not applicable b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not applicable d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: 7 Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The plazomicin interpretative criteria for disk diffusion in the approved pharmaceutical drug package insert is located at the FDA STIC website and shown in Table 2 below. Table 2: Interpretative Criteria for Plazomicin Disk Indications For Use Organism(s) Interpretative Criteria Zone Diameter (mm) R I S Enterobacteriaceae ≤13 14-15 ≥16 The QC isolates and expected ranges are the same as recommended by the current (28th) edition of CLSI M100. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK181700_s2000_e4000

K181700.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

overexpression of efflux pumps (e.g., acrAB-tolC) or lower expression of porins (e.g., ompF or ompK36). 1. Analytical performance: a. Precision/Reproducibility: Not applicable b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Not applicable d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: 7 Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The plazomicin interpretative criteria for disk diffusion in the approved pharmaceutical drug package insert is located at the FDA STIC website and shown in Table 2 below. Table 2: Interpretative Criteria for Plazomicin Disk Indications For Use Organism(s) Interpretative Criteria Zone Diameter (mm) R I S Enterobacteriaceae ≤13 14-15 ≥16 The QC isolates and expected ranges are the same as recommended by the current (28th) edition of CLSI M100. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150281_s0_e2000

K150281.txt

purpose for submission

Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Purpose for submission:

idK150281_s0_e2000

K150281.txt

measurand

Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Measurand:

idK150281_s0_e2000

K150281.txt

type of test

Quantitative amperometric assay, glucose oxidase

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Type of test:

idK150281_s0_e2000

K150281.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Classification:

idK150281_s0_e2000

K150281.txt

product code

CGA, Glucose Oxidase, Glucose

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Product code:

idK150281_s0_e2000

K150281.txt

panel

Clinical Chemistry (75)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Panel:

idK150281_s0_e2000

K150281.txt

intended use

See Indications for Use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Intended use:

idK150281_s0_e2000

K150281.txt

predicate device name

Nova StatStrip Glucose Hospital Meter System

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Predicate device name:

idK150281_s0_e2000

K150281.txt

applicant

Nova Biomedical Corporation

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Applicant:

idK150281_s0_e2000

K150281.txt

proprietary and established names

StatStrip Glucose Hospital Meter System

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Proprietary and established names:

idK150281_s0_e2000

K150281.txt

regulation section

21 CFR 862.1345, Glucose test system

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k150281 B. Purpose for Submission: Modified device to add wireless (Wi-Fi) connectivity, modify the meter layout and revise the accompanying docking/charging station. C. Measurand: Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples. D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. 2 The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration. The system has not been evaluated for use with neonate venous blood. Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. Use only whole blood. Do not use serum or plasma. Should only be used with single-use, auto-disabling lancing devices 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: 3 The StatStrip Glucose Hospital Meter System, previously cleared under k060345, k063821 and k132121, has been modified in meter layout and to include a wireless (Wi-Fi) connectivity option which provides an additional communication method with a healthcare facility’s network system. Additionally, the docking station has been revised to accommodate an additional meter. The modified system consists of the StatStrip Glucose Hospital meter (with integrated Wi-Fi connection and antenna option), StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), charging station, battery (3.7V lithium), Quick Reference Guide, and User Manual. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): K132121 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) Brand Name Nova StatStrip Glucose Hospital Meter System Same Indications for Use/Intended Use For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. Same Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Venous and arterial whole blood, neonatal arterial whole blood, and Same 4 Similarities and Differences Item Predicate Device (k132121) Candidate Device (k150281) neonatal heelstick in all hospital and all professional healthcare settings. Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 µL Same Control solutions 3 liquid levels Same Linearity solutions 5 liquid levels Same Data Storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity None Yes Meter dimension and weight 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in) 266 grams (0.6 lb) 146 mm (5.8 in) x 79 mm (3.1 in) x 30 mm (1.18 in) 220 grams (0.49 lb) Strip ejector button None Yes Docking/Charging Station single station only single, dual and quad stations K. Standard/Guidance Document Referenced (if applicable): • IEC/EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. • BS EN 55011:2009+A1:2010: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement • EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): This submission was for adding wireless (Wi-Fi) connectivity and minor modifications to meter layout. The Test Strips, Control Solutions and Linearity Kit Solutions were not modified from the predicate. 1. Analytical performance: 5 a. Precision/Reproducibility: As established in k060345 b. Linearity/assay reportable range: As established in k063821. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability was established in k060345. Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label. Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345. Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed- vial stability is 24 months at 33-86°F and 10-90% RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. . d. Detection limit: The reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: As established in k132121. In this submission, an additional method comparison study was performed using the modified device by trained technicians who tested 86 native whole blood samples and 14 contrived samples (with glucose concentrations <70 mg/dL or >360 mg/dL) using 3 devices and 3 lots of test strips. All samples were tested in singlicate on the 6 candidate device an on an YSI 2300 reference analyzer. The results for each of the 3 meter/strip lot tested is displayed below: System accuracy results vs. YSI for glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL Meter 1 12/ Regulation section:

idK150281_s2000_e4000

K150281.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

%) 13/13 (100%) 13/13 (100%) Meter 2 10/13 (76.9%) 13/13 (100%) 13/13 (100%) Meter 3 11/13 (84.6%) 13/13 (100%) 13/13 (100%) System accuracy results vs. YSI for glucose concentrations ≥75 mg/dL Within ± 5% Within ± 10% Within ± 15% Within ± 20% Meter 1 63/87 (72.4%) 87/87 (100%) 87/87 (100%) 87/87 (100%) Meter 2 53/87 (60.9%) 83/87 (95.4%) 87/87 (100%) 87/87 (100%) Meter 3 65/87 (74.7%) 83/87 (95.4%) 87/87 (100%) 87/87 (100%) b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 140 mg/dL (7.77 mmol/L) 1-2 hours after meals American Diabetes Association. Diabetes Care (2013), Volume 36, Supplement 1. N. Instrument Name: Nova StatStrip Glucose Hospital Meter O. System Description: 1. Modes of Operation: 7 Each test strip is single use and must be replaced with a new strip for additional readings. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?: Yes X or No . Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?: Yes X or No . 2. Software: FDA has reviewed the software for the modified StatStrip Glucose Hospital Meter with Wi-Fi option. The software development, validation &verification processes are acceptable. 3. Specimen Identification: The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators. 4. Specimen Sampling and Handling: The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action. The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, QC preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station. 5. Calibration: As established in k060345, the meter does not require the user to input a test strip code. 6. Quality Control: Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used. 8 P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: 1) Hematocrit study: As established in k060345 and k063821 to support the claimed hematocrit range of 20- 65%. 2) Altitude study: As established in k060345 to support the use of the device up to 15,000 ft. 3) Temperature and humidity studies: As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity. 4) Infection Control Studies: The device is intended for multiple-patient use. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes, EPA registration # 67619-12 was validated for use with the meter. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the modified StatStrip Glucose Hospital Meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) using the Clorox Germicidal Wipes to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 5) Electromagnetic Compatibility and Electrical Safety: The modified StatStrip Glucose Hospital Meter System with Wi-Fi option has been tested to meet the applicable requirements. 6) Wireless Data Transmission Test: Six Nova StatStrip Glucose Hospital Meters with wireless option were used in a wireless data transmission functional testing at a representative hospital environment. A total of 654 results were transmitted from various locations in the hospital. Study protocols and acceptance criteria were reviewed and were found to be acceptable. The study results demonstrated that test results can be transmitted accurately and securely via the Wi-Fi function and that the device can coexist with other wireless devices in the intended environment. 7) Customer Care Service Center is available by calling 800-545-6682. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 9 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150281_s2000_e4000

K150281.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

.3%) 13/13 (100%) 13/13 (100%) Meter 2 10/13 (76.9%) 13/13 (100%) 13/13 (100%) Meter 3 11/13 (84.6%) 13/13 (100%) 13/13 (100%) System accuracy results vs. YSI for glucose concentrations ≥75 mg/dL Within ± 5% Within ± 10% Within ± 15% Within ± 20% Meter 1 63/87 (72.4%) 87/87 (100%) 87/87 (100%) 87/87 (100%) Meter 2 53/87 (60.9%) 83/87 (95.4%) 87/87 (100%) 87/87 (100%) Meter 3 65/87 (74.7%) 83/87 (95.4%) 87/87 (100%) 87/87 (100%) b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 140 mg/dL (7.77 mmol/L) 1-2 hours after meals American Diabetes Association. Diabetes Care (2013), Volume 36, Supplement 1. N. Instrument Name: Nova StatStrip Glucose Hospital Meter O. System Description: 1. Modes of Operation: 7 Each test strip is single use and must be replaced with a new strip for additional readings. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?: Yes X or No . Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?: Yes X or No . 2. Software: FDA has reviewed the software for the modified StatStrip Glucose Hospital Meter with Wi-Fi option. The software development, validation &verification processes are acceptable. 3. Specimen Identification: The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators. 4. Specimen Sampling and Handling: The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action. The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, QC preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station. 5. Calibration: As established in k060345, the meter does not require the user to input a test strip code. 6. Quality Control: Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used. 8 P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: 1) Hematocrit study: As established in k060345 and k063821 to support the claimed hematocrit range of 20- 65%. 2) Altitude study: As established in k060345 to support the use of the device up to 15,000 ft. 3) Temperature and humidity studies: As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity. 4) Infection Control Studies: The device is intended for multiple-patient use. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes, EPA registration # 67619-12 was validated for use with the meter. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the modified StatStrip Glucose Hospital Meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) using the Clorox Germicidal Wipes to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 5) Electromagnetic Compatibility and Electrical Safety: The modified StatStrip Glucose Hospital Meter System with Wi-Fi option has been tested to meet the applicable requirements. 6) Wireless Data Transmission Test: Six Nova StatStrip Glucose Hospital Meters with wireless option were used in a wireless data transmission functional testing at a representative hospital environment. A total of 654 results were transmitted from various locations in the hospital. Study protocols and acceptance criteria were reviewed and were found to be acceptable. The study results demonstrated that test results can be transmitted accurately and securely via the Wi-Fi function and that the device can coexist with other wireless devices in the intended environment. 7) Customer Care Service Center is available by calling 800-545-6682. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 9 R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK182353_s0_e2000

K182353.txt

purpose for submission

Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Purpose for submission:

idK182353_s0_e2000

K182353.txt

measurand

IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Measurand:

idK182353_s0_e2000

K182353.txt

type of test

Automated semi-quantitative solid-phase fluoroimmunoassays

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Type of test:

idK182353_s0_e2000

K182353.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Classification:

idK182353_s0_e2000

K182353.txt

panel

Immunology (82)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Panel:

idK182353_s0_e2000

K182353.txt

indications for use

Same as Intended Uses

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Indications for use:

idK182353_s0_e2000

K182353.txt

predicate device name

EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Predicate device name:

idK182353_s0_e2000

K182353.txt

applicant

Phadia AB

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Applicant:

idK182353_s0_e2000

K182353.txt

proprietary and established names

EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182353 B. Purpose for Submission: Addition of previously cleared assays on a new instrument platform (Phadia 2500/5000) C. Measurand: IgG autoantibodies specific to Centromere protein (CENP), U1 ribonucleoprotein (U1RNP), and ribonucleoprotein 70kDa (RNP70) D. Type of Test: Automated semi-quantitative solid-phase fluoroimmunoassays E. Applicant: Phadia AB F. Proprietary and Established Names: EliA CENP Immunoassay, EliA U1RNP Immunoassay, El RNP70 Immunoassay G. Regulatory Information: 1. Regulatory Section: 21 CFR 866.5100, Antinuclear antibody immunological test system 2. Classification: Class II Product Codes: 3. LJM, Antinuclear Antibody (Enzyme-labeled), Antigen, Controls LKO, Anti-RNP Antibody, Antigen and Control 2 4. Panel: Immunology (82) H. Intended uses Intended Use: 1. : EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000. 2. Indication for uses: Same as Intended Uses 3. Special conditions for use statement: Prescription use only 4. Special instrument requirements: For use on the Phadia 2500 and Phadia 5000 instruments I. Device Description: EliA uses a modular reagent system. The assay-specific, method-specific and general reagents are packaged and purchased as separate units. The reagents on Phadia 2500 and Phadia 5000 are identical; they are only filled in different containers. 3 (1) EliA Assay-Specific reagent: · EliA CENP Wells are coated with human recombinant centromere protein B in two carriers (12 wells each), ready to use; · EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A, C) proteins in four carriers (12 wells each), ready to use; · EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein in four carriers (12 wells each), ready to use; (2) EliA Method-specific reagent: · EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single- use vials per strip, 0.3 mL each, ready to use; · EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide in five strips, six single-use vials per strip, 0.3 mL each, ready to use; · EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide in six bottles, 48 mL each, ready to use; or six bottles, 400 mL each, ready to use; · EliA IgG Conjugate 50 or 200: β-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide in 6 wedge-shaped bottles, 5 mL each, ready to use; or six wedge-shaped bottles, 19 mL each, ready to use; · EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies in four carriers (12 wells each), ready to use; (3) EliA General reagents: · Development Solution (0.01 %4-Methylumbelliferyl-β-D-galacto-side, <0.0010% preservative), ready for use; · Stop Solution (4% Sodium Carbonate), ready for use; · Dilution Wells (high density polyethylene wells), 50 carriers, ready to use; · Pipette Tips in Racks (polyethylene tips), 24 racks × 160 tips, ready for use; · Washing Solution (information in separate Washing Solution package insert) Phadia 2500 and Phadia 5000 are identical instruments except for sample throughput. The Phadia 2500 consists of one process module (two process lines), whereas Phadia 5000 consists of two process modules (2 x 2 process lines). Instrument operation is handled by onboard Instrument Software (ISW). Data output is administered by Information Data Manager (IDM). All steps of an assay are performed within a single process line. Thus, study protocols used for Phadia 2500 are also valid for Phadia 5000. J. Substantial Equivalence Information: 1. Predicate device name: EliA CENP on Phadia 250, EliA U1RNP on Phadia 250, EliA RNP70 on Phadia 250 4 2. Predicate 510(k) number: K082759 (EliA CENP and EliA U1RNP) K083117 (EliA RNP70) 3. Comparison with predicate: Similarities Item Predicate Device Phadia 250 Test Device Phadia 2500/5000 Intended Use/Indications for Use EliA CENP EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li- heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA U1RNP EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument ImmunoCAP 250. EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000. Intended Use/Indications for Use EliA RNP70 EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 is to be used together with the EliA IgG method on the instrument ImmunoCAP 250. EliA RNP70 is intended for the in vitro semi Proprietary and established names:

idK182353_s8000_e10000

K182353.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

5000 400 1.5 1.5 0.4–3.9 2.2 3.0 EliA RNP70 on Phadia 2500/5000 400 1.4 1.4 0.1–3.7 2.2 2.5 N. Proposed Labelling: The labelling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK170491_s0_e2000

K170491.txt

purpose for submission

To obtain a substantial equivalence determination for a new device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Purpose for submission:

idK170491_s0_e2000

K170491.txt

measurand

tcdA gene of toxigenic Clostridium difficile

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Measurand:

idK170491_s0_e2000

K170491.txt

type of test

Qualitative Helicase-Dependent Amplification (HDA) assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Type of test:

idK170491_s0_e2000

K170491.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Classification:

idK170491_s0_e2000

K170491.txt

product code

OZN

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Product code:

idK170491_s0_e2000

K170491.txt

panel

Microbiology (83)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Panel:

idK170491_s0_e2000

K170491.txt

intended use

The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Intended use:

idK170491_s0_e2000

K170491.txt

predicate device name

Portrait Toxigenic C. difficile Assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Predicate device name:

idK170491_s0_e2000

K170491.txt

applicant

Quidel Corporation

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Applicant: