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idK171742_s0_e2000

K171742.txt

panel

Immunology (82)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl- L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera Panel:

idK171742_s0_e2000

K171742.txt

indications for use

Same as Intended Uses

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl- L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera Indications for use:

idK171742_s0_e2000

K171742.txt

applicant

Siemens Healthcare Diagnostics Products GmbH

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl- L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera Applicant:

idK171742_s6000_e8000

K171742.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

endogenous and exogenous substances with their corresponding concentration labels as shown below: Interference Study Interferent (Endogenous and Exogenous) Concentration level RF 2000 IU/mL Hemoglobin 10 g/L Bilirubin conjugated 1025 µmol/L Bilirubin unconjugated 618 µmol/L Triglycerides 5 g/L Total Protein 143 g/L Amikacin 136.8 µmol/L Acetamidophenol 1324 µmol/L Ascorbic Acid 342 µmol/L Caffeine 308 µmol/L Creatinine 5 mg/dL Erythromycin 81.6 µmol/L Acetylsalicylic Acid 3.62 µmol/L Dextran 60 g/L Carbamazepine 127 µmol/L Ethosuximide 1770 µmol/L Ibuprofen 2425 µmol/L Lidocaine 51.2 µmol/L Penicillin 161 µmol/L Urea 42.9 mmol/L 14 Uric Acid 1.4 mmol/L Valproic Acid 3467 µmol/L Dexamethasone 1.53 µmol/L Cimetidine 79.2 µmol/L Chlorpromazine 6.3 µmol/L Ethanol 100 mg/dL Digoxin 7.8 nmol/L Furosemide 181 µmol/L Phenytoin 198 µmol/L Primidone 183 µmol/L Nicotine 6.2 µmol/L Chlordiazepoxide 33.3 µmol/L Diazepam 18 µmol/L Pentobarbital 431 µmol/L Dextropropoxyphene 4.91 µmol/L Heparin Ammonium Salt 3000 U/L Heparin Lithium Salt 3000 U/L Heparin Sodium Salt 3000 U/L Gentamicin 21 µmol/L Lithium Chloride 3.2 mmol/L Aminophylline Hydrate (Theophylline) 222 µmol/L Chloramphenicol 155 µmol/L Melphalan 4000 ng/mL Human Anti-Mouse Antibody (HAMA): No HAMA interferent was observed in both FLC Kappa and FLC Lambda assays with HAMA samples up to 15.47 mg/L. The Package Insert states: “Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.” f. Assay cut-off: See expected values/reference range. 2. Comparison studies: a. Method comparison with predicate device: 219 samples were tested with the Siemens N Latex FLC Kappa and Lambda assays and the results were compared to the results of the predicate devices. A total of 96 MM and a total of 83 AL serum samples spanning the dynamic range of one or both assays were used in this study. In addition, samples from 24 donors with polyclonal 15 immunoglobulin stimulation and 16 with Chronic Kidney Disease (CKD) were included. 216 of these samples yielded quantitative values in both kappa assays and 218 in both lambda assays. Kit N Sample Range N Latex FLC mg/L Slope (Passing Bablock) 95% CI (Slope) Y- Intercept (Passing Babloc) 95% CI (Y- Intercept) R2 FLC Kappa 216 1.38 – 13,400 0.794 0.742 – 0.852 2.112 1.134 – 2.785 0.889 FLC Lambda 218 0.924 – 24,300 1.170 1.014– 1.318 2.163 0.723 – 3.881 0.950 b. Matrix comparison: Matrix comparison studies were performed between serum and EDTA plasma on 44 samples. Results are as follows: Serum versus EDTA Plasma FLC Kappa Summary N=44 Regression Passing Bablock Slope (95% CI) PB Intercept (95% CI) Median Difference Serum vs EDTA r = 0.98 1.014 (0.967 – 1.036) - 0.791 (-1.250 – 0.050) -3.5% Serum versus EDTA Plasma FLC Lambda Summary N=44 Regression Passing Bablock Slope (95% CI) PB Intercept (95% CI) Median Difference Serum vs EDTA r = 0.99 1.050 (1.005 – 1.094) - 1.10 (-1.91 – -0.19) -1.0% 3. Clinical studies: a. Clinical Sensitivity and specificity: A total of 342 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 96 samples from MM patients, 83 samples from AL patients and 163 samples from non-myeloma patients with various clinical conditions: 24 samples from polyclonal immunoglobulin stimulation patients; 16 samples from CKD patients & 123 samples from other 16 clinical condition patients. For MM, a total of 259 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 96 samples from Multiple Myeloma patients, and 163 samples from non-myeloma patients with various clinical conditions. Clinical sensitivity and specificity summary of the N Latex FLC Kappa and Lambda Ratio for MM are shown in the table below (using the FLC Kappa and Lambda Ratio Reference Interval of 0.53–1.51 as cut-off): Clinical Diagnosis of MM Positive Negative Total N Latex FLC Kappa and Lambda Ratio Positive 92 5 97 Negative 4 158 162 Total 96 163 259 Clinical Sensitivity: 95.8% (95% CI: 89.8 – 98.4%) Clinical Specificity: 96.9% (95% CI: 93.0 – 98.7%) For AL, a total of 246 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 83 samples from AL Amyloidosis patients, and 163 non-AL Amyloidosis samples from patients with various clinical conditions. Clinical sensitivity and specificity summary of the N Latex FLC Kappa and Lambda Ratio for AL are shown in the table below (using the FLC Kappa and Lambda Ratio Reference Interval of 0.53–1.51 as cut-off): Clinical Diagnosis of AL Positive Negative Total N Latex FLC Kappa and Lambda Ratio Positive 69 5 74 Negative 14 158 172 Total 83 163 246 Clinical Sensitivity: 83.1% (95% CI: 73.7 – 89.7%) Clinical Specificity: 96.9% (95% CI: 93.0 – 98.7%) b. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 17 5. Expected values/Reference range: Reference intervals were determined from a US-population of 201 apparently healthy subjects. The reference intervals were calculated nonparametrically and represent the central 95 % range of the population. The following reference intervals apply for serum and plasma samples from healthy adults: FLC Kappa: 8.24 – 28.9 mg/L (2.5th – 97.5th percentile) FLC Lambda: 9.10 – 32.6 mg/L (2.5th – 97.5th percentile) FLC Kappa/ Lambda Ratio: 0.53 – 1.51 (median 1.0st – 99.0th percentile) The Package Insert states: “Nevertheless, each laboratory should determine its own reference intervals since values may vary depending on the individual population studied.” N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK171742_s6000_e8000

K171742.txt

conclusion

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

lists of endogenous and exogenous substances with their corresponding concentration labels as shown below: Interference Study Interferent (Endogenous and Exogenous) Concentration level RF 2000 IU/mL Hemoglobin 10 g/L Bilirubin conjugated 1025 µmol/L Bilirubin unconjugated 618 µmol/L Triglycerides 5 g/L Total Protein 143 g/L Amikacin 136.8 µmol/L Acetamidophenol 1324 µmol/L Ascorbic Acid 342 µmol/L Caffeine 308 µmol/L Creatinine 5 mg/dL Erythromycin 81.6 µmol/L Acetylsalicylic Acid 3.62 µmol/L Dextran 60 g/L Carbamazepine 127 µmol/L Ethosuximide 1770 µmol/L Ibuprofen 2425 µmol/L Lidocaine 51.2 µmol/L Penicillin 161 µmol/L Urea 42.9 mmol/L 14 Uric Acid 1.4 mmol/L Valproic Acid 3467 µmol/L Dexamethasone 1.53 µmol/L Cimetidine 79.2 µmol/L Chlorpromazine 6.3 µmol/L Ethanol 100 mg/dL Digoxin 7.8 nmol/L Furosemide 181 µmol/L Phenytoin 198 µmol/L Primidone 183 µmol/L Nicotine 6.2 µmol/L Chlordiazepoxide 33.3 µmol/L Diazepam 18 µmol/L Pentobarbital 431 µmol/L Dextropropoxyphene 4.91 µmol/L Heparin Ammonium Salt 3000 U/L Heparin Lithium Salt 3000 U/L Heparin Sodium Salt 3000 U/L Gentamicin 21 µmol/L Lithium Chloride 3.2 mmol/L Aminophylline Hydrate (Theophylline) 222 µmol/L Chloramphenicol 155 µmol/L Melphalan 4000 ng/mL Human Anti-Mouse Antibody (HAMA): No HAMA interferent was observed in both FLC Kappa and FLC Lambda assays with HAMA samples up to 15.47 mg/L. The Package Insert states: “Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.” f. Assay cut-off: See expected values/reference range. 2. Comparison studies: a. Method comparison with predicate device: 219 samples were tested with the Siemens N Latex FLC Kappa and Lambda assays and the results were compared to the results of the predicate devices. A total of 96 MM and a total of 83 AL serum samples spanning the dynamic range of one or both assays were used in this study. In addition, samples from 24 donors with polyclonal 15 immunoglobulin stimulation and 16 with Chronic Kidney Disease (CKD) were included. 216 of these samples yielded quantitative values in both kappa assays and 218 in both lambda assays. Kit N Sample Range N Latex FLC mg/L Slope (Passing Bablock) 95% CI (Slope) Y- Intercept (Passing Babloc) 95% CI (Y- Intercept) R2 FLC Kappa 216 1.38 – 13,400 0.794 0.742 – 0.852 2.112 1.134 – 2.785 0.889 FLC Lambda 218 0.924 – 24,300 1.170 1.014– 1.318 2.163 0.723 – 3.881 0.950 b. Matrix comparison: Matrix comparison studies were performed between serum and EDTA plasma on 44 samples. Results are as follows: Serum versus EDTA Plasma FLC Kappa Summary N=44 Regression Passing Bablock Slope (95% CI) PB Intercept (95% CI) Median Difference Serum vs EDTA r = 0.98 1.014 (0.967 – 1.036) - 0.791 (-1.250 – 0.050) -3.5% Serum versus EDTA Plasma FLC Lambda Summary N=44 Regression Passing Bablock Slope (95% CI) PB Intercept (95% CI) Median Difference Serum vs EDTA r = 0.99 1.050 (1.005 – 1.094) - 1.10 (-1.91 – -0.19) -1.0% 3. Clinical studies: a. Clinical Sensitivity and specificity: A total of 342 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 96 samples from MM patients, 83 samples from AL patients and 163 samples from non-myeloma patients with various clinical conditions: 24 samples from polyclonal immunoglobulin stimulation patients; 16 samples from CKD patients & 123 samples from other 16 clinical condition patients. For MM, a total of 259 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 96 samples from Multiple Myeloma patients, and 163 samples from non-myeloma patients with various clinical conditions. Clinical sensitivity and specificity summary of the N Latex FLC Kappa and Lambda Ratio for MM are shown in the table below (using the FLC Kappa and Lambda Ratio Reference Interval of 0.53–1.51 as cut-off): Clinical Diagnosis of MM Positive Negative Total N Latex FLC Kappa and Lambda Ratio Positive 92 5 97 Negative 4 158 162 Total 96 163 259 Clinical Sensitivity: 95.8% (95% CI: 89.8 – 98.4%) Clinical Specificity: 96.9% (95% CI: 93.0 – 98.7%) For AL, a total of 246 samples were included in the clinical validation study for the N Latex FLC Kappa and Lambda assay. This validation set included 83 samples from AL Amyloidosis patients, and 163 non-AL Amyloidosis samples from patients with various clinical conditions. Clinical sensitivity and specificity summary of the N Latex FLC Kappa and Lambda Ratio for AL are shown in the table below (using the FLC Kappa and Lambda Ratio Reference Interval of 0.53–1.51 as cut-off): Clinical Diagnosis of AL Positive Negative Total N Latex FLC Kappa and Lambda Ratio Positive 69 5 74 Negative 14 158 172 Total 83 163 246 Clinical Sensitivity: 83.1% (95% CI: 73.7 – 89.7%) Clinical Specificity: 96.9% (95% CI: 93.0 – 98.7%) b. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 17 5. Expected values/Reference range: Reference intervals were determined from a US-population of 201 apparently healthy subjects. The reference intervals were calculated nonparametrically and represent the central 95 % range of the population. The following reference intervals apply for serum and plasma samples from healthy adults: FLC Kappa: 8.24 – 28.9 mg/L (2.5th – 97.5th percentile) FLC Lambda: 9.10 – 32.6 mg/L (2.5th – 97.5th percentile) FLC Kappa/ Lambda Ratio: 0.53 – 1.51 (median 1.0st – 99.0th percentile) The Package Insert states: “Nevertheless, each laboratory should determine its own reference intervals since values may vary depending on the individual population studied.” N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK151767_s0_e2000

K151767.txt

purpose for submission

New devices

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Purpose for submission:

idK151767_s0_e2000

K151767.txt

measurand

Sodium, Potassium, Chloride, Albumin

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Measurand:

idK151767_s0_e2000

K151767.txt

type of test

Quantitative, photometry, and ion selective multisensors for electrolytes

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Type of test:

idK151767_s0_e2000

K151767.txt

panel

Chemistry (75)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Panel:

idK151767_s0_e2000

K151767.txt

intended use

See Indications for use below

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Intended use:

idK151767_s0_e2000

K151767.txt

predicate device name

Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Predicate device name:

idK151767_s0_e2000

K151767.txt

applicant

Siemens Healthcare Diagnostics Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151767 B. Purpose for Submission: New devices C. Measurand: Sodium, Potassium, Chloride, Albumin D. Type of Test: Quantitative, photometry, and ion selective multisensors for electrolytes E. Applicant: Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Trinidad CH system TD-LYTE Integrated Multisensor (Na, K, Cl) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator G. Regulatory Information: Product Code Classification Regulation Section Panel JGS Class II 21 CFR 862.1665 Sodium Test System Clinical Chemistry (75) CEM 21 CFR 862.1600 Potassium Test System CGZ 21 CFR 862.1170 Chloride Test System CJW 21 CFR 862.1035 Albumin Test System JIT 21 CFR 862.1150 Calibrator (single analyte) JIX 21 CFR 862.1150 Calibrator (multiple analytes) JJE Class I, exempt 21 CFR 862.2160 Discrete Photometric Analyzer Chemistry For Clinical Use 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system’s chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use. The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Trinidad CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The TD-LYTE Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na, K, and Cl on the Trinidad CH System. The Trinidad CH Albumin BCP Reagent (Alb_P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Trinidad CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. The Trinidad CH Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (Alb_P) on the Trinidad CH System. 3. Special conditions for use statement(s): For prescription use only 3 4. Special instrument requirements: Trinidad CH System I. Device Description: The Siemens Healthcare Diagnostics Trinidad CH system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies (IMT) for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).The TD-LYTE IMT system consists of the following: • TD-LYTE Integrated Multisensor (Na, K, Cl): four electrodes (one ion-selective electrode for Na, K, Cl, respectively, and one reference electrode. • TD-LYTE IMT Standard A & Standard B + Salt-bridge: calibrators used for calibration of Na, K, and Cl assays. The salt bridge solution is packaged together with the Standard B calibrator. The target concentrations of the TD-LYTE IMT Standard A include: Na+ at 14 mmol/L, K+ at 0.4 mmol/L and Cl- at 10.4 mmol/L. The target concentrations of the TD-LYTE IMT Standard B include: Na+ at 7 mmol/L, K+ at 6 mmol/L and Cl- at 16 mmol/L. The target concentrations of the Salt Bridge include: K+ at 120.0 mmol/L and Cl- at 120.0 mmol/L. • TD-LYTE IMT Diluent: A diluent consists of tetramethyl ammonium hydroxide, phosphoric acid, BSA preservative, buffer, preservative and surfactant. All samples are pre-diluted (1:10) with this diluent before analyzing. • TD-LYTE IMT Dilution Check: solution used for verification of the Trinidad CH system dilution ratio during instrument preventive maintenance or if indicated by quality control results. The Trinidad CH Albumin BCP Reagent (Alb_P) consists of Reagent R1 (bromocresol purple, 1.1 mmol/L, acetate buffer, surfactant and microbial inhibitor). The Trinidad CH Albumin BCP Calibrator is a lyophilized human serum-based product containing albumin with a target concentration of 4.3 g/dL. The Trinidad CH Albumin BCP Reagent (Alb_P) and Calibrator are the same reagent and calibrator as those cleared in the predicate device (k132664), which are repackaged with the Trinidad CH System labeling. Each donation of human blood or blood component human was tested by FDA approved methods and found non-reactive for the presence of the antibody to Human Immunodeficiency Virus 1 and 2 (HIV 1/2), the Hepatitis B surface antigen (HBsAg), and the antibody to Hepatitis C (HCV). 4 J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA 1800 Chemistry System including ISE and Albumin BCP Assays 2. Predicate 510(k) number(s): K990346, K132664 3. Comparison with predicate: Instrument Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Similarities Type of System Random continuous access, batch, discrete processing Same Types of Measurements Quantitative, photometry, and ion selective multisensors for electrolytes Same Throughput Rate 1800 tests/hour, 1200 tests/hour colorimetric, 600 tests/hour ISE Same Sample Containers Tubes - 5 mL, 7 mL, 10 mL Cups - 2 mL sample cups Same Sample Type Whole blood, serum, plasma, CSF or urine Same Auto-dilution Automatic dilution from retained pre-diluted sample Same QC provide stored control results, Levy- Jennings plotting, and statistics Same Differences Optical system Water bath and cuvette optical path length (7 mm) Oil bath and cuvette optical path length (10 mm) Assay Capacity On-board Up to 70 slots including 3 ISE 56 slots including 3 ISE Assays Endpoint, rate reaction, 2-point rate, sample blank correction. Endpoint, rate reaction, 2-point rate. Reaction Times 3, 4, 5, 10, 15 and 21 minutes 3 to 10 minutes Auto-repeat Automatic repeat testing from the retained pre-diluted sample Automatic repeat testing from the retained pre-diluted sample or original sample Auto-reflex Not available Ability to perform 3 additional tests based on results of first test Photometer 11 fixed wavelengths 14 fixed wavelengths (12 utilized) 5 Item Trinidad CH System (Candidate Device k151767) ADVIA 1800 Chemistry System (Predicate Device K990346) Light Source 12 V, 50 W Halogen lamp / cooled by lamp coolant additive and one LED 12V, 50W halogen lamp, cooled by forced water circulation Bar Codes Interleaved 2 of 5, code 39, code 128, Codabar (NW7), reagent pack data matrix 2D Interleaved 2 of 5, code 39, code 128, Codabar (NW7) Power Requirements 200-240 VAC +/–10%, 8Amp, 50/60 Hz, 3.2 KVA 200/220/230 V +/–10%, 30Amp, 50/60 Hz, 3 KVA Dimensions Analytical Module: 136.35 (h) x 145.25 (w) x 118.33 (d) cm Direct Load: 136.5 (h) x 42.53 (w) x115.0 (d) cm 113.3 (h) x 148.0 (w) x 87.7 (d) cm Result Database Stores up to 1 million results. 7 days of results maintained in a flat Applicant:

idK151767_s8000_e10000

K151767.txt

proposed labeling

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

, Wilmington, DE, August 1982. N. Instrument Name: Trinidad CH system O. System Descriptions: 1. Modes of Operation: Random continuous access, batch, or discrete processing 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 ________ or No ___X_____ 2. Software: The software for the Trinidad CH system is determined to have a moderate level of concern. 19 FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: Manual entry or barcode identification 4. Specimen Sampling and Handling: Samples are identified and delivered by the sample handler (Direct Load), which is part of the Trinidad CH system. 5. Calibration: The Trinidad CH System IMT system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power on, with the changing of standards A, B, or a sensor and when the system software is reset. In addition, a new calibration is required under the following conditions: • After major maintenance or service, if indicated by quality control results • As indicated in laboratory quality control procedures • When required by government regulations The Trinidad CH Albumin BCP assay should be calibrated if one or more of the following conditions exist: • At the end of the 8-day (per well) pack calibration interval, for calibrated reagent packs on the system • At the end of the 30-day lot calibration interval, for a specified lot of calibrated reagent on the system • When replacing system components • When the reagent lot number changes • After replacing critical optical or hydraulic components • When indicated by quality control procedures 6. Quality Control: The sponsor recommends on their labeling that “Follow government regulations or accreditation requirements for quality control frequency. At least once each day of use, analyze 2 levels (low and high) of commercially available quality control (QC) material with known Na, K, Cl, albumin concentrations.” 20 P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: A urine dilution recovery study was performed to extend the reportable ranges up to 600 mmol/L for Na, 600 mmol/L for K, and 660 mmol/L for Cl by manually diluting 1 part urine with 1 part reagent grade water. A carry-over study has been performed and found to be acceptable. 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:

idK151767_s8000_e10000

K151767.txt

conclusion

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

Pont Company, Wilmington, DE, August 1982. N. Instrument Name: Trinidad CH system O. System Descriptions: 1. Modes of Operation: Random continuous access, batch, or discrete processing 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 ________ or No ___X_____ 2. Software: The software for the Trinidad CH system is determined to have a moderate level of concern. 19 FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: Manual entry or barcode identification 4. Specimen Sampling and Handling: Samples are identified and delivered by the sample handler (Direct Load), which is part of the Trinidad CH system. 5. Calibration: The Trinidad CH System IMT system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power on, with the changing of standards A, B, or a sensor and when the system software is reset. In addition, a new calibration is required under the following conditions: • After major maintenance or service, if indicated by quality control results • As indicated in laboratory quality control procedures • When required by government regulations The Trinidad CH Albumin BCP assay should be calibrated if one or more of the following conditions exist: • At the end of the 8-day (per well) pack calibration interval, for calibrated reagent packs on the system • At the end of the 30-day lot calibration interval, for a specified lot of calibrated reagent on the system • When replacing system components • When the reagent lot number changes • After replacing critical optical or hydraulic components • When indicated by quality control procedures 6. Quality Control: The sponsor recommends on their labeling that “Follow government regulations or accreditation requirements for quality control frequency. At least once each day of use, analyze 2 levels (low and high) of commercially available quality control (QC) material with known Na, K, Cl, albumin concentrations.” 20 P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: A urine dilution recovery study was performed to extend the reportable ranges up to 600 mmol/L for Na, 600 mmol/L for K, and 660 mmol/L for Cl by manually diluting 1 part urine with 1 part reagent grade water. A carry-over study has been performed and found to be acceptable. 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:

idK182472_s0_e2000

K182472.txt

purpose for submission

To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Purpose for submission:

idK182472_s0_e2000

K182472.txt

type of test

The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Type of test:

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K182472.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Classification:

idK182472_s0_e2000

K182472.txt

product code

PMN: Assayed external control material for microbiology nucleic acid amplification

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Product code:

idK182472_s0_e2000

K182472.txt

panel

83 - Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Panel:

idK182472_s0_e2000

K182472.txt

intended use

The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Intended use:

idK182472_s0_e2000

K182472.txt

predicate device name

Bio-Rad Amplichek II

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Predicate device name:

idK182472_s0_e2000

K182472.txt

applicant

Microbiologics, Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Applicant:

idK182472_s0_e2000

K182472.txt

proprietary and established names

Cepheid Xpert GBS LB Control Panel

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Proprietary and established names:

idK182472_s0_e2000

K182472.txt

regulation section

21 CFR 866.3920: Assayed quality control material for clinical microbiology assays

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: K182472 B. Purpose for Submission: To obtain a Substantial Equivalence determination for the Cepheid Xpert GBS LB Control Panel for use with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acid quality control material from inactivated Streptococcus agalactiae and Lactobacillus acidophilus bacterial cultures for detection of Streptococcus agalactiae (Group B Streptococcus positive control) and Lactobacillus acidophilus (negative control). D. Type of Test: The Cepheid Xpert GBS LB Control Panel is an external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Streptococcus agalactiae (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Cepheid Xpert GBS LB Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 2 3. Product code: PMN: Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: 83 - Microbiology H. Intended Use: 1. Intended use(s): The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. This product is not intended to replace the manufacturer controls provided with the Cepheid Xpert GBS LB Assay. 4. Special instrument requirements: The Cepheid Xpert GBS LB Control Panel is intended for use on the Cepheid GeneXpert Instrument System 3 I. Device Description: The Cepheid Xpert GBS LB Control Panel (Assayed Microbiology Control) is used to monitor DNA extraction, amplification and detection by the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. Each Panel consists of 6 individually packaged positive control swabs of Streptococcus agalactiae (Lancefield’s Group B) and 6 individually packaged negative control swabs of Lactobacillus acidophilus. The swabs were prepared with cultured, heat-inactivated, lyophilized organisms. When tested on the GeneXpert Instrument System using the Cepheid Xpert GBS LB Assay, S. agalactiae gives a Positive result and L. acidophilus gives a Negative result. J. Substantial Equivalence Information: 1. Predicate device name(s): Bio-Rad Amplichek II 2. Predicate 510(k) number(s): DEN150058 3. Comparison with predicate: 4 Table 1. Comparison of the Cepheid Xpert GBS LB Control Panel with the Predicate Device Similarities Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II DEN150058 Intended Use External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. External assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. Composition Cultured and inactivated microorganisms Same Test System Cepheid GeneXpert System Same Directions for Use Process like patient sample Same Assay Steps Monitored Extraction, amplification, and detection Same 5 Differences Item Device Cepheid Xpert GBS LB Control Panel K182472 Predicate Bio-Rad Amplichek II – DEN150058 Physical Format Lyophilized swab Ready-to-use- liquid Analytes · Positive Control: Streptococcus agalactiae · Negative Control: Lactobacillus acidophilus · Methicillin Resistant Staphylococcus aureus · Methicillin Sensitive Staphylococcus aureus · Clostridium difficile · Vancomycin-resistant Enterococci Assay Compatibility Cepheid Xpert GBS LB Assay (K121539) · Cepheid Xpert MRSA/SA Blood Culture Assay (K130894) · Cepheid Xpert MRSA (K070462) · Cepheid Xpert SA Nasal Complete (K100822) · Cepheid Xpert MRSA/SA SSTI (K080837) · Cepheid Xpert C. difficile (K091109) · Cepheid Xpert C. difficile/Epi (K110203) · Cepheid Xpert vanA (K092953) K. Standard/Guidance Document Referenced (if applicable): CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. L. Test Principle: The Cepheid Xpert GBS LB Control Panel is intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the Cepheid Xpert GBS LB Assay (K121539) on the GeneXpert Instrument System. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Studies to determine precision and reproducibility of the Cepheid Xpert GBS LB Control Panel were performed on the GeneXpert Instrument using the Cepheid Xpert GBS LB assay. Testing was done at three different locations over five days. At each location, two operators each tested three different lots of control material for a total of 90 test results each for the Positive and Negative Control swabs (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates in total). A summary of the qualitative results for both the Positive and Negative Controls are provided in Table 2. All Positive Controls produced the expected Positive result, although one control was re-tested due to an instrument ERROR which indicated that the assay was aborted. When re- tested, the Positive Control produced the expected result. All Negative Controls produced the expected Negative result. Table 2. Summary of results from the Reproducibility Study (qualitative) Positive Control (PC) Test location Total Tests Performed Invalid Tests Correct PC Result Incorrect PC Result Percent Correct2 11 31 1 30 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 1 90 0 100% Negative Control (NC) Test location Total Tests Performed Invalid Tests Correct NC Result Incorrect NC Result Percent Correct2 11 31 0 31 0 100% 2 30 0 30 0 100% 3 30 0 30 0 100% All sites 91 0 91 0 100% 1 One ERROR result was observed for the positive control. Both the positive control and negative control were re-tested, as indicated in the test protocol. 2 Data from the test run with the ERROR result was not included in the Percent Correct analysis. The reproducibility of the Cepheid Xpert GBS LB Control Panel within and between test locations, GeneXpert Instruments, operators, and lots was determined to be acceptable. b. Linearity/assay reportable range: Not applicable. 7 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: Not applicable. Stability: 1. Shelf-life stability was established through an Accelerated Stability Study that was performed with three lots of the Positive Control from the Cepheid Xpert G Regulation section:

idK182472_s2000_e4000

K182472.txt

proposed labeling

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

The Positive Control was placed at elevated temperatures (43˚C, 53˚C and 63˚C) and tested in four replicates at four time points (Day 0, Day 14, Day 28 and Day 42). When the stability of the product was evaluated qualitatively, all analytes tested positive on the GeneXpert Instrument System using the Cepheid Xpert GBS LB assay. Thus, the data provided no evidence of product degradation under the conditions tested and may support shelf-life claims of 24 months. 2. A Real-Time, Shelf-Life Stability Study is in process with a goal of a 24 months stability claim. Positive Control samples incubated at two temperatures (2-8°C and 25°C) will be qualitatively tested four times throughout a 25 months study (four samples/sampling). Testing is expected to be completed by 08/27/2020. 3. An In-Use Stability Study was done to determine if the Positive and Negative Control products would remain stable for five hours after hydration to demonstrate stability of the product within the recommended time frame of use (i.e., ≤15 minutes). Two replicates from a single lot were hydrated and set aside (in a centrifuge tube) at room temperature (21°C). Samples were tested on the GeneCpert System after zero, four, and six hours and gave expected values indicating that the product may be hydrated and used within a six hour period without concern of performance. Expected Values: The Cepheid Xpert GBS LB Control Panel is a qualitative conrol expected to produce positive results with the Positive Control (Streptococcus agalactiae) and negative results with the Negative Control (Lactobacillus acidophilus) when tested with the Cepheid Xpert GBS LB assay using the GeneXpert Instrument System. d. Detection limit: Not applicable. e. Analytical specificity: Not applicable. 8 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. 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 Cepheid Xpert GBS LB Control Panel is a qualitative quality control panel with no assigned values. Performance was evaluated as described in Section M. 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:

idK182472_s2000_e4000

K182472.txt

conclusion

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

Panel. The Positive Control was placed at elevated temperatures (43˚C, 53˚C and 63˚C) and tested in four replicates at four time points (Day 0, Day 14, Day 28 and Day 42). When the stability of the product was evaluated qualitatively, all analytes tested positive on the GeneXpert Instrument System using the Cepheid Xpert GBS LB assay. Thus, the data provided no evidence of product degradation under the conditions tested and may support shelf-life claims of 24 months. 2. A Real-Time, Shelf-Life Stability Study is in process with a goal of a 24 months stability claim. Positive Control samples incubated at two temperatures (2-8°C and 25°C) will be qualitatively tested four times throughout a 25 months study (four samples/sampling). Testing is expected to be completed by 08/27/2020. 3. An In-Use Stability Study was done to determine if the Positive and Negative Control products would remain stable for five hours after hydration to demonstrate stability of the product within the recommended time frame of use (i.e., ≤15 minutes). Two replicates from a single lot were hydrated and set aside (in a centrifuge tube) at room temperature (21°C). Samples were tested on the GeneCpert System after zero, four, and six hours and gave expected values indicating that the product may be hydrated and used within a six hour period without concern of performance. Expected Values: The Cepheid Xpert GBS LB Control Panel is a qualitative conrol expected to produce positive results with the Positive Control (Streptococcus agalactiae) and negative results with the Negative Control (Lactobacillus acidophilus) when tested with the Cepheid Xpert GBS LB assay using the GeneXpert Instrument System. d. Detection limit: Not applicable. e. Analytical specificity: Not applicable. 8 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. 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 Cepheid Xpert GBS LB Control Panel is a qualitative quality control panel with no assigned values. Performance was evaluated as described in Section M. 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:

idK143548_s0_e2000

K143548.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Purpose for submission:

idK143548_s0_e2000

K143548.txt

measurand

Capillary whole blood glucose from the fingertip

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Measurand:

idK143548_s0_e2000

K143548.txt

type of test

Quantitative Amperometric assay (FAD-Glucose Dehydrogenase)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Type of test:

idK143548_s0_e2000

K143548.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Classification:

idK143548_s0_e2000

K143548.txt

panel

Clinical Chemistry (75)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Panel:

idK143548_s0_e2000

K143548.txt

intended use

See indication(s) for use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Intended use:

idK143548_s0_e2000

K143548.txt

predicate device name

Bayer Ascensia Contour Blood Glucose Monitoring System

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Predicate device name:

idK143548_s0_e2000

K143548.txt

applicant

Trividia Health, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Applicant:

idK143548_s0_e2000

K143548.txt

proprietary and established names

TRUE METRIX™ GO Blood Glucose Monitoring System

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Proprietary and established names:

idK143548_s0_e2000

K143548.txt

regulation section

21 CFR 862.1345, Glucose test system

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k143548 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip D. Type of Test: Quantitative Amperometric assay (FAD-Glucose Dehydrogenase) E. Applicant: Trividia Health, Inc. F. Proprietary and Established Names: TRUE METRIX™ GO Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. 3. Special conditions for use statement(s): • For In-Vitro Diagnostic Use Only. • For over-the-counter use • Not for screening or diagnosis of diabetes mellitus • Not for use on critically ill patients, patients in shock, dehydrated patients or hyper- osmolar patients • Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. • Capillary whole blood only from the fingertip may be used for testing • Do not use on neonates • For single-patient use only 4. Special instrument requirements: 3 TRUE METRIXTM GO Blood Glucose Meter I. Device Description: The TRUE METRIX GO Self Monitoring Blood Glucose System contains a blood glucose meter and TRUE METRIXTM Blood Glucose Test Strips. These are no code meters. The meter is designed to affix (twist) onto the cap of a TRUE METRIX strip vial. The test strip vial and its flip-top cap are molded as a single unit so that when the meter is attached to the vial cap, the meter and strip vial may be handled by the user as a single unit. True Metrix Control Solutions (three levels: Level 1, 2 and 3) were previously cleared under k120989. Control solutions must be purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Ascensia Contour Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062058 3. Comparison with predicate: Similarities of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Intended Use/Indications for Use It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. same Detection method Electrochemical Biosensor Same Enzyme FAD-Glucose Dehydrogenase Same Calibration Coding Auto coding Same 4 Differences of the Blood Glucose System Item Predicate Device Bayer Ascensia Contour Blood Glucose Monitoring System (k062058) Candidate Device TRUE METRIX GO Self Monitoring Blood Glucose System (k143548) Memory 480 test results 500 test results Test range 10 - 600 mg/dL 20-600 mg/dL Sample sites Fresh Capillary Whole Blood from the fingertip, forearm, palm, venous whole blood, arterial and neonate whole blood Fresh Capillary Whole Blood from the fingertip Sample volume 0.6 µL 0.5 µL Hematocrit range 0-70% 20-70% Altitude Study Up to 10,000 feet Up to 10,200 feet Glucose measuring range 10-600 mg/dL 20-600 mg/dL Operating Temperature 41-113 °F 40-86 °F Operating Humidity 10-93% RH 10-80% RH Glucose Assay Time 5 seconds 4-7 seconds K. Standard/Guidance Document Referenced (if applicable): • IEC 60601-1-2, Medical electrical equipment Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic Compatibility- Requirements and tests. • CLSI GP14-A, Labeling of Home-Use In Vitro Testing Products • CEN 13640:2002 Stability Testing of in vitro Diagnostic Reagents • CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline. 5 L. Test Principle: The TRUE METRIX GO Self Monitoring Blood Glucose System uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method. The system employs flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) 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): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples collected from a single donor. The whole blood tubes were allowed to glycolyze or were spiked with 30% glucose solution at the following glucose concentrations: 25, 40, 80, 140, 200, 320, 500 mg/dL across the claimed range and tested on three lots of production strips on 30 meters (10 meters per test strip lot). Ten replicates were tested per meter, test strip lot and glucose concentration. Results are summarized below: Glucose Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV (22-28) 100 1 24 1.0 4.2 2 22 0.9 4.3 3 22 0.9 4.0 (36-44) 100 1 38 1.4 3.7 2 38 1.5 3.9 3 36 1.4 3.7 (76-84) 100 1 75 2.2 3.0 2 74 2.4 3.2 3 73 2.6 3.5 (133-147) 100 1 138 3.8 2.8 2 137 5.0 3.6 3 139 4.8 3.4 (190-210) 100 1 206 7.3 3.6 2 203 6.7 3.3 3 206 6.5 3.2 (304-336) 100 1 291 10.9 3.7 2 294 10.1 3.4 3 299 7.4 2.5 (475-525) 100 1 490 12.7 2.6 2 495 15.0 3.0 3 509 12.7 2.5 6 Intermediate Precision Intermediate precision was evaluated using three lots of test strips and ten meters. Glucose control solutions in three concentration ranges were used (Level 1, Level 2 and Level 3). For each test strip lot, each control solution was measured once per day on 10 meters. Each concentration was tested in replicates of 10, with three test strip lots on 10 days, so that 100 individual measurements were generated (300 measurements per glucose level). Results are summarized below: Control Level (mg/dL) n Strip Lot Mean (mg/dL) SD (mg/dL) %CV Level 1 100 1 37 1.5 4.0 2 38 1.8 4.8 3 36 1.4 3.9 Level 2 100 1 112 4.1 3.6 2 115 4.0 3.5 3 116 3.6 3.1 Level 3 100 1 312 10.1 3.2 2 319 12.6 3.9 3 322 10.6 2.8 b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood samples at 9 different glucose levels Samples with the following glucose concentrations (mg/dL): 22, 40, 91, 176, 277, 368, 449, 559, 685, were prepared by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 8 times. Linear regression analysis for each test strip lot compared to the YSI. The results from the regression analysis are summarized below: y = 1.012x + 0.754; R2 = 0.9987 for the combined lots The results of the study support the sponsor’s claimed glucose measurement range of 20- 600 mg/dL. c. Traceability, Regulation section:

idK143548_s4000_e6000

K143548.txt

proposed labeling

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

The effect of altitude was evaluated with 3 test strip lots tested on 5 meters using venous blood (spiked and glycolyzed) from 3 donors to 3 glucose concentrations (38-43, 121-127, 529-559). The samples were tested at 10,200 feet above sea level. Results obtained were compared with those obtained with the reference method (YSI). The results demonstrate acceptable bias to the reference to support the claims in the labeling that altitudes up to 10,200 feet have no significant effect on blood glucose measurements from the BGMS. 3. Hematocrit Study: The effect of different hematocrit levels was evaluated using venous whole blood samples with hematocrit levels of 20 – 70% (20, 30, 42, 55 and 70%) spiked with glucose to achieve target concentrations of 40, 75, 120, 350, and 500 mg/dL. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (42%) hematocrit as well as to the corresponding YSI value. The % bias of the TRUEMETRIX GO meter results relative to YSI demonstrated adequate performance to support the claimed hematocrit range of 20 – 70%. 4. Test System operating conditions: 13 Operating conditions were evaluated for temperatures ranging from 41oF-104oF (5°C- 40°C) and relative humidity from 10% to 90% including extreme combinations of temperature and humidity. The following temperature and relative humidity (RH) conditions were tested: ≤5°C and 10% RH, ≤5°C and 90% RH, 20°C and 50% RH, 30°C and 50% RH, 40°C and 10% RH, 40°C and 90% RH. Individual glucose measurements were compared to the YSI reference method and a percent bias was calculated. Protocol and acceptance criteria were provided and found to be acceptable. The results supported the Sponsor’s claimed operating temperature from 41oF-104oF and relative humidity range from 10% to 80%. 5. Readability Assessment: The readability of the labeling (user guide, quick reference guide and test strip insert) using a Flesch-Kincaid analysis were found to be written at the 8th grade level. 6. EMC Testing: The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the TRUE METRIX+ GO Blood Glucose Monitoring System was found compliant. 7. Infection Control Studies: The device system is intended for single-patient use only. 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, Super Sani-Cloth Germicidal Wipes (EPA Registration # 9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleanings and 260 disinfection steps with the 580 wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 8. Customer Support Center assistance, call 24/7 toll free 1-800-803-6025 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:

idK143548_s4000_e6000

K143548.txt

conclusion

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

Study: The effect of altitude was evaluated with 3 test strip lots tested on 5 meters using venous blood (spiked and glycolyzed) from 3 donors to 3 glucose concentrations (38-43, 121-127, 529-559). The samples were tested at 10,200 feet above sea level. Results obtained were compared with those obtained with the reference method (YSI). The results demonstrate acceptable bias to the reference to support the claims in the labeling that altitudes up to 10,200 feet have no significant effect on blood glucose measurements from the BGMS. 3. Hematocrit Study: The effect of different hematocrit levels was evaluated using venous whole blood samples with hematocrit levels of 20 – 70% (20, 30, 42, 55 and 70%) spiked with glucose to achieve target concentrations of 40, 75, 120, 350, and 500 mg/dL. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (42%) hematocrit as well as to the corresponding YSI value. The % bias of the TRUEMETRIX GO meter results relative to YSI demonstrated adequate performance to support the claimed hematocrit range of 20 – 70%. 4. Test System operating conditions: 13 Operating conditions were evaluated for temperatures ranging from 41oF-104oF (5°C- 40°C) and relative humidity from 10% to 90% including extreme combinations of temperature and humidity. The following temperature and relative humidity (RH) conditions were tested: ≤5°C and 10% RH, ≤5°C and 90% RH, 20°C and 50% RH, 30°C and 50% RH, 40°C and 10% RH, 40°C and 90% RH. Individual glucose measurements were compared to the YSI reference method and a percent bias was calculated. Protocol and acceptance criteria were provided and found to be acceptable. The results supported the Sponsor’s claimed operating temperature from 41oF-104oF and relative humidity range from 10% to 80%. 5. Readability Assessment: The readability of the labeling (user guide, quick reference guide and test strip insert) using a Flesch-Kincaid analysis were found to be written at the 8th grade level. 6. EMC Testing: The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the TRUE METRIX+ GO Blood Glucose Monitoring System was found compliant. 7. Infection Control Studies: The device system is intended for single-patient use only. 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, Super Sani-Cloth Germicidal Wipes (EPA Registration # 9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleanings and 260 disinfection steps with the 580 wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 8. Customer Support Center assistance, call 24/7 toll free 1-800-803-6025 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:

idK172913_s0_e2000

K172913.txt

purpose for submission

To obtain clearance for a new device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Purpose for submission:

idK172913_s0_e2000

K172913.txt

measurand

Factor II and Factor V

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Measurand:

idK172913_s0_e2000

K172913.txt

type of test

Genotyping test

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Type of test:

idK172913_s0_e2000

K172913.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Classification:

idK172913_s0_e2000

K172913.txt

panel

Hematology (81)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Panel:

idK172913_s0_e2000

K172913.txt

applicant

Roche Molecular Systems, Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Applicant:

idK172913_s0_e2000

K172913.txt

proprietary and established names

cobas® Factor II and Factor V Test

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Proprietary and established names:

idK172913_s0_e2000

K172913.txt

regulation section

21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K172913 B. Purpose for Submission: To obtain clearance for a new device C. Measurand: Factor II and Factor V D. Type of Test: Genotyping test E. Applicant: Roche Molecular Systems, Inc. F. Proprietary and Established Names: cobas® Factor II and Factor V Test G. Regulatory Information: 1. Regulation section: 21 CFR 84.7280; Factor V Leiden DNA Mutation Detection Systems 2. Classification: Class II 3. Product code: NPR; Test, Factor II G20210A Mutations, Genomic DNA PCR, Factor V Leiden DNA Mutation Detection Systems NPQ; Test, Factor V Leiden Mutations, Genomics DNA PCR, Factor V Leiden DNA Mutation Detection Systems 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): The cobas® Factor II and Factor V Test is an in vitro diagnostic device that uses real- time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The cobas® Factor II and Factor V Test and cobas z 480 analyzer are used together for automated amplification and detection. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): Prescription Use only 4. Special instrument requirements: cobas z 480 analyzer I. Device Description: The cobas Factor II and Factor V Test is a real-time polymerase chain reaction (PCR) test for the qualitative detection and genotyping of a single point mutation in the human Factor V gene (G to A at position 1691, referred to as the Factor V Leiden mutation) and a single point mutation in the human Factor II gene (G to A at position 20210), in genomic DNA isolated from peripheral whole blood, as an aid in diagnosis of patients with suspected thrombophilia. The assay consists of one reagent kit and a system platform. The reagent kit provides the necessary reagents and controls to perform automated real-time PCR amplification and detection. The system platform consists of real-time PCR thermal cycler (cobas z 480 analyzer) and a control unit (cobas 4800 System CU). J. Substantial Equivalence Information: 1. Predicate device name(s): Roche Factor II (Prothrombin) G20210A Kit Roche Factor V Leiden Kit 3 2. Predicate 510(k) number(s): K033612 K033607 (DEN030005) 3. Comparison with predicate: Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Intended Use The cobas Factor II and Factor V Test is an in vitro diagnostic device that uses real-time PCR for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation in genomic DNA obtained from K2EDTA whole blood specimens as an aid in diagnosis of patients with suspected thrombophilia. The test is performed on the cobas z 480 analyzer for automated amplification and detection. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Same except the predicate device was cleared on the LightCycler 1.2 analyzer. Type of Test Genotyping test Same Same Target of Detection Single nucleotide mutation Same Same Indication for Use Aid in the diagnosis of patients with suspected thrombophilia Same Same Intended User Healthcare professionals Same Same Specimen Type Purified DNA from Same Same 4 Similarities Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 human blood samples Differences Item Device: cobas Factor II and Factor V Test (K172913) Predicate: Roche Factor II (Prothrombin) G20210A Kit K033612 Predicate: Roche Factor V Leiden Kit K033607 Technological Detection Principles Real-time PCR test for simultaneous amplification of two targets and detection of specific SNPs in the PCR amplified DNA sequences (multiplex system) Real-time PCR test for amplification of one target and detection of specific SNP in PCR- amplified DNA sequences Real-time PCR test for amplification of one target and detection of specific SNP in PCR-amplified DNA sequences Oligonucleotide probes and primers Specific for Factor V G1691A, Factor II G20210A and the wild- type Factor II and Factor V sequences Specific for Factor II G20210A and Factor II wild-type sequences Specific for Factor V Leiden G1691A and Factor V wild- type sequences Detection Chemistry Fluorogenic detection of SNPs in each PCR amplification product by allele-specific cleavage of TaqMan probes Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Fluorogenic detection of SNP in PCR amplification product by melting curve analysis Analytical Sensitivity <50 allele copies (0.01 ng input DNA/reaction) Approximately 50 allele copies per reaction Approximately 50 allele copies per reaction Instrument cobas z 480 Roche LightCycler version 1.2 Roche LightCycler version 1.2 Controls Endogenous internal control (each gene is internal control for other gene), plus external positive and negative controls required in each run External positive and negative controls required in each run External positive and negative controls required in each run Reference method Bi-directional Sanger sequencing Sanger sequencing Sanger sequencing 5 K. Standard/Guidance Document Referenced (if applicable): CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline – 2nd Edition L. Test Principle: DNA is extracted offline from whole blood specimens collected in K2EDTA tubes. The user- selected DNA extraction method must provide DNA of sufficient concentration. Automated real-time PCR is then performed on the cobas z 480 analyzer. The Factor II and Factor V mutations are detected simultaneously in the same real-time PCR reaction. The amplification reactions generate a Factor II specific amplicon and Factor V specific amplicon in all samples, and utilize four fluorescent-dye labeled oligonucleotide probes for detection of the Factor II and Factor V genotypes. Depending upon the test order, results for one or both mutations are reported for each DNA sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Lot-to-Lot Repeatability: The lot-to-lot repeatability of the cobas Factor II and Factor V Test was evaluated by testing genomic DNA samples isolated from seven K2EDTA whole blood samples with three lots of the cobas Factor II and Factor V Test. The study was conducted over five non-consecutive days with two operators, two cobas z 480 analyzers, one run per day per kit lot, and two replicates per run, for a total of 60 replicates of each sample. The cobas Factor II and Factor V Test results were compared to the Factor II and Factor V genotype by bi-directional Sanger sequencing. The overall agreement between cobas Factor II and Factor V Test results and nucleic acid sequencing was 100% across all samples and reagent lots (one-sided, lower 95% confidence limit 99.3%). The table below summarizes the study results by individual lots and combined lots. 6 Sample ID Factor II Genotype Factor V Genotype Number of Tests per Lot Number (%) Correct Genotype Results Lot 1 Lot 2 Lot 3 Lot 4 S1 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S2 Wild Type Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S3 Wild Type Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S4 Heterozygous Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S5 Wild Type Homozygous mutant 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S6 Homozygous mutant Wild Type 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) S7 Heterozygous Heterozygous 20 20 (100%) 20 (100%) 20 (100%) 60 (100%) Total 140 140 (100%) 140 (100%) 140 (100%) 420 (100%) Clinical Reproducibility: A panel of nine specimens was tested at three sites, two operators per site, with one instrument per site and three lots of reagent lots with one lot per site. Each site had one operator which performed one run per day using one sample preparation method over five non-consecutive days. Reproducibility was assessed using a nine member panel as demonstrated in the table below: four K2EDTA whole blood samples, three contrived whole Regulation section:

idK172913_s6000_e8000

K172913.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

>T, 20218A>G, 20221C>T, 1689G>A, 1690C>T, 1692A>C and 1696A>G) in the probe binding regions of the cobas Factor II and Factor V Test were tested. The Factor II SNP plasmids and the Factor V SNP plasmids were wild type at positions 20210 and 1691, respectively. Each SNP plasmid DNA was tested alone, and in combination with wild type Factor II plasmid DNA, wild type Factor V plasmid DNA, wild type Factor II and wild type Factor V plasmid DNAs, and with genomic DNA from wild type whole blood. None of the SNP plasmids caused false positive results for the Factor II (prothrombin) or Factor V Leiden mutations, and none of the SNP plasmids interfered with detection of the wild type Factor II or Factor V sequences. All four Factor II SNP plasmids and three of four Factor V SNP plasmids were detected as wild type Factor II or Factor V DNA, respectively. One Factor V SNP plasmid (1689G>A) was not detected by the cobas Factor II and Factor V Test. If this SNP is present on both alleles, the test result would be invalid. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: A total of 300 specimens from patients whose routine medical care called for Factor II and/or Factor V measurements were obtained to represent the intended use population. The commercial vendors that provided these samples indicated that the collection included the genotypes as demonstrated in the table below. 14 Factor II and Factor V genotypes included in the method comparison study Factor II (F2) Factor V (F5) Specimen Type Wild Type (WT F2) Wild Type (WT F5) K2EDTA whole blood Wild Type (WT F2) Heterozygous (HET F5) K2EDTA whole blood Heterozygous (HET F2) Wild Type (WT F5) K2EDTA whole blood Heterozygous (HET F2) Heterozygous (HET F5) K2EDTA whole blood Wild Type (WT F2) Homozygous (MUT F5) K2EDTA whole blood Homozygous (MUT F2) Wild Type (WT F5) K2EDTA whole blood and gDNA One external site conducted testing with the cobas Factor II and Factor V test. One commercial laboratory performed bi-directional Sanger sequencing. The 300 samples were randomized and tested by two operators. All samples were tested for Factor II and Factor V by both cobas Factor II and Factor V Test and Sanger sequencing. All runs and tests were valid for the cobas test and no repeat tests were performed. A test result was classified as correct for Factor II or Factor V if both the cobas test and Sanger sequencing detected the same genotype. The table below presents agreement between the cobas test and Sanger sequencing for Factor II results. The Overall Percentage Agreement (OPA) between the two tests was 100% with a two-sided 95% lower confidence bound (exact method) of 98.78%. Both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were 100% with lower confidence bounds of 97.59% for PPA and 97.55% for NPA. The percent agreement of correct results for heterozygous and homozygous mutant genotypes were both 100%. Performance of the cobas Factor II and Factor V Test using Bi-directional Sanger Sequencing as a Reference for the Identification of Factor II Genotype Genotype by Sequencing Total Samples Tested Correct Calls1 No calls or Invalid Results2 Missed or Incorrect Calls3 Percent Agreement 95% LCB4 Wild Type 149 149 0 0 100% NPA 97.55% Positive 151 151 0 0 100% PPA 97.59% Heterozygous 130 130 0 0 100% 97.20% Mutant5 21 21 0 0 100% 83.89% Total 300 300 0 0 100% OPA 98.78% 1cobas test Factor II genotype results in agreement with the Factor II genotype by Sanger sequencing 2Invalid or failed cobas result (no Factor II genotype call) 3cobas test Factor II genotype results discordant with the Factor II genotype by sequencing 4Two-sided 95% lower confidence boundary is calculated using Exact method 5Homozygous mutant For Factor V, the table below presents agreement between the cobas test and Sanger sequencing for Factor V results. The OPA between the two tests was 100% with a two-sided 95% lower confidence bound (exact method) of 98.78%. Both PPA and NPA were 100% with lower confidence bounds of 97.62% for PPA and 97.52% for NPA. The percent agreement of correct results for heterozygous and homozygous mutant genotypes were both 100%. 15 Performance of the cobas Factor II and Factor V Test using Bi-Directional Sanger Sequencing as a Reference for the Identification of Factor V Genotype Genotype by Sequencing Total Samples Tested Correct Calls1 No calls or Invalid Results2 Missed or Incorrect Calls3 Percent Agreement 95% LCB4 Wild Type 147 147 0 0 100% NPA 97.52% Positive 153 153 0 0 100% PPA 97.62% Heterozygous 130 130 0 0 100% 97.20% Mutant5 23 23 0 0 100% 85.18% Total 300 300 0 0 100% OPA 98.78% 1cobas test Factor V genotype results in agreement with the Factor V genotype by Sanger sequencing 2Invalid or failed cobas result (no Factor V genotype call) 3cobas test Factor V genotype results discordant with the Factor V genotype by sequencing 4Two-sided 95% lower confidence boundary is calculated using Exact method 5Homozygous mutant The table below presents method comparison study results for the combined Factor II and Factor V results. Bi-Directional Sanger Sequencing Result cobas Factor II and Factor V Test Result Total HET F2/HET F5 HET F2/WT F5 MUT F2/WT F5 WT F2/HET F5 WT F2/MUT F5 WT F2/WT F5 HET F2/HET F5 25 0 0 0 0 0 25 HET F2/WT F5 0 105 0 0 0 0 105 MUT F2/WT F5 0 0 21 0 0 0 21 WT F2/HET F5 0 0 0 105 0 0 105 WT F2/MUT F5 0 0 0 0 23 0 23 WT F2/WT F5 25 105 21 105 23 21 300 b. Matrix comparison: Matched frozen and fresh K2EDTA whole blood samples were compared and resulted in 100% correct genotype results. 3. Clinical studies: a. Clinical Sensitivity: Not applicable 16 b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): DNA Extraction Method Study: Genomic DNA was isolated from 15 whole blood samples using three commercially available DNA isolation methods according to the manufacturer’s instructions, by two operators for three days, for a total of six DNA isolations per sample with each DNA isolation method. Each isolated gDNA sample was tested in triplicate with the cobas Factor II and Factor V Test. One hundred percent of the results with the cobas Factor II and Factor V Test were in agreement with the Factor II and Factor V genotype by bi-directional Sanger sequencing. One gDNA sample was excluded from the results as it was rust colored and yielded invalid results in all three tests. The table below summaries the results from the DNA extraction method study. DNA Isolation Method Total number of Number (%) of DNA Isolations Tests Correct Results Incorrect Results Invalid Results A 90 270 267a (98.9%) (96.8 – 99.8)b 0 (0.0%) 3a (1.1%) B 90 270 268c (99.3%) (97.4 – 99.9)b 1c (0.4%) 1c (0.4%) C 90 270 270 (100%) 98.6 – 100)b 0 (0.0%) 0 (0.0%) Total 270 810 805 (99.4%) (98.6 – 99.8)b 1 (0.1%) 4 (0.5%) aOne of 90 DNA samples isolated with method A was rust-colored and generated three invalid results. DNA samples with any appearance other than clear and colorless should not be tested, as they may yield invalid or incorrect results. b95% two-sided, confidence interval cThe triplicate results from one sample isolated with method B were inconsistent: one correct, one incorrect, one invalid. The sample eluate was re-tested in triplicate and all results were correct upon testing. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. 17 O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK172913_s6000_e8000

K172913.txt

conclusion

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

9C>T, 20218A>G, 20221C>T, 1689G>A, 1690C>T, 1692A>C and 1696A>G) in the probe binding regions of the cobas Factor II and Factor V Test were tested. The Factor II SNP plasmids and the Factor V SNP plasmids were wild type at positions 20210 and 1691, respectively. Each SNP plasmid DNA was tested alone, and in combination with wild type Factor II plasmid DNA, wild type Factor V plasmid DNA, wild type Factor II and wild type Factor V plasmid DNAs, and with genomic DNA from wild type whole blood. None of the SNP plasmids caused false positive results for the Factor II (prothrombin) or Factor V Leiden mutations, and none of the SNP plasmids interfered with detection of the wild type Factor II or Factor V sequences. All four Factor II SNP plasmids and three of four Factor V SNP plasmids were detected as wild type Factor II or Factor V DNA, respectively. One Factor V SNP plasmid (1689G>A) was not detected by the cobas Factor II and Factor V Test. If this SNP is present on both alleles, the test result would be invalid. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: A total of 300 specimens from patients whose routine medical care called for Factor II and/or Factor V measurements were obtained to represent the intended use population. The commercial vendors that provided these samples indicated that the collection included the genotypes as demonstrated in the table below. 14 Factor II and Factor V genotypes included in the method comparison study Factor II (F2) Factor V (F5) Specimen Type Wild Type (WT F2) Wild Type (WT F5) K2EDTA whole blood Wild Type (WT F2) Heterozygous (HET F5) K2EDTA whole blood Heterozygous (HET F2) Wild Type (WT F5) K2EDTA whole blood Heterozygous (HET F2) Heterozygous (HET F5) K2EDTA whole blood Wild Type (WT F2) Homozygous (MUT F5) K2EDTA whole blood Homozygous (MUT F2) Wild Type (WT F5) K2EDTA whole blood and gDNA One external site conducted testing with the cobas Factor II and Factor V test. One commercial laboratory performed bi-directional Sanger sequencing. The 300 samples were randomized and tested by two operators. All samples were tested for Factor II and Factor V by both cobas Factor II and Factor V Test and Sanger sequencing. All runs and tests were valid for the cobas test and no repeat tests were performed. A test result was classified as correct for Factor II or Factor V if both the cobas test and Sanger sequencing detected the same genotype. The table below presents agreement between the cobas test and Sanger sequencing for Factor II results. The Overall Percentage Agreement (OPA) between the two tests was 100% with a two-sided 95% lower confidence bound (exact method) of 98.78%. Both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were 100% with lower confidence bounds of 97.59% for PPA and 97.55% for NPA. The percent agreement of correct results for heterozygous and homozygous mutant genotypes were both 100%. Performance of the cobas Factor II and Factor V Test using Bi-directional Sanger Sequencing as a Reference for the Identification of Factor II Genotype Genotype by Sequencing Total Samples Tested Correct Calls1 No calls or Invalid Results2 Missed or Incorrect Calls3 Percent Agreement 95% LCB4 Wild Type 149 149 0 0 100% NPA 97.55% Positive 151 151 0 0 100% PPA 97.59% Heterozygous 130 130 0 0 100% 97.20% Mutant5 21 21 0 0 100% 83.89% Total 300 300 0 0 100% OPA 98.78% 1cobas test Factor II genotype results in agreement with the Factor II genotype by Sanger sequencing 2Invalid or failed cobas result (no Factor II genotype call) 3cobas test Factor II genotype results discordant with the Factor II genotype by sequencing 4Two-sided 95% lower confidence boundary is calculated using Exact method 5Homozygous mutant For Factor V, the table below presents agreement between the cobas test and Sanger sequencing for Factor V results. The OPA between the two tests was 100% with a two-sided 95% lower confidence bound (exact method) of 98.78%. Both PPA and NPA were 100% with lower confidence bounds of 97.62% for PPA and 97.52% for NPA. The percent agreement of correct results for heterozygous and homozygous mutant genotypes were both 100%. 15 Performance of the cobas Factor II and Factor V Test using Bi-Directional Sanger Sequencing as a Reference for the Identification of Factor V Genotype Genotype by Sequencing Total Samples Tested Correct Calls1 No calls or Invalid Results2 Missed or Incorrect Calls3 Percent Agreement 95% LCB4 Wild Type 147 147 0 0 100% NPA 97.52% Positive 153 153 0 0 100% PPA 97.62% Heterozygous 130 130 0 0 100% 97.20% Mutant5 23 23 0 0 100% 85.18% Total 300 300 0 0 100% OPA 98.78% 1cobas test Factor V genotype results in agreement with the Factor V genotype by Sanger sequencing 2Invalid or failed cobas result (no Factor V genotype call) 3cobas test Factor V genotype results discordant with the Factor V genotype by sequencing 4Two-sided 95% lower confidence boundary is calculated using Exact method 5Homozygous mutant The table below presents method comparison study results for the combined Factor II and Factor V results. Bi-Directional Sanger Sequencing Result cobas Factor II and Factor V Test Result Total HET F2/HET F5 HET F2/WT F5 MUT F2/WT F5 WT F2/HET F5 WT F2/MUT F5 WT F2/WT F5 HET F2/HET F5 25 0 0 0 0 0 25 HET F2/WT F5 0 105 0 0 0 0 105 MUT F2/WT F5 0 0 21 0 0 0 21 WT F2/HET F5 0 0 0 105 0 0 105 WT F2/MUT F5 0 0 0 0 23 0 23 WT F2/WT F5 25 105 21 105 23 21 300 b. Matrix comparison: Matched frozen and fresh K2EDTA whole blood samples were compared and resulted in 100% correct genotype results. 3. Clinical studies: a. Clinical Sensitivity: Not applicable 16 b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): DNA Extraction Method Study: Genomic DNA was isolated from 15 whole blood samples using three commercially available DNA isolation methods according to the manufacturer’s instructions, by two operators for three days, for a total of six DNA isolations per sample with each DNA isolation method. Each isolated gDNA sample was tested in triplicate with the cobas Factor II and Factor V Test. One hundred percent of the results with the cobas Factor II and Factor V Test were in agreement with the Factor II and Factor V genotype by bi-directional Sanger sequencing. One gDNA sample was excluded from the results as it was rust colored and yielded invalid results in all three tests. The table below summaries the results from the DNA extraction method study. DNA Isolation Method Total number of Number (%) of DNA Isolations Tests Correct Results Incorrect Results Invalid Results A 90 270 267a (98.9%) (96.8 – 99.8)b 0 (0.0%) 3a (1.1%) B 90 270 268c (99.3%) (97.4 – 99.9)b 1c (0.4%) 1c (0.4%) C 90 270 270 (100%) 98.6 – 100)b 0 (0.0%) 0 (0.0%) Total 270 810 805 (99.4%) (98.6 – 99.8)b 1 (0.1%) 4 (0.5%) aOne of 90 DNA samples isolated with method A was rust-colored and generated three invalid results. DNA samples with any appearance other than clear and colorless should not be tested, as they may yield invalid or incorrect results. b95% two-sided, confidence interval cThe triplicate results from one sample isolated with method B were inconsistent: one correct, one incorrect, one invalid. The sample eluate was re-tested in triplicate and all results were correct upon testing. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. 17 O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK181915_s0_e2000

K181915.txt

purpose for submission

New device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Purpose for submission:

idK181915_s0_e2000

K181915.txt

measurand

Glycosylated hemoglobin (HbA1c)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Measurand:

idK181915_s0_e2000

K181915.txt

type of test

Quantitative Immunoassay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Type of test:

idK181915_s0_e2000

K181915.txt

intended use

See indications for use below.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Intended use:

idK181915_s0_e2000

K181915.txt

predicate device name

SD A1cCare System and SD A1cCare Spoit Type Test Kit

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Predicate device name:

idK181915_s0_e2000

K181915.txt

applicant

iXensor Co., LTD.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Applicant:

idK181915_s0_e2000

K181915.txt

proprietary and established names

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181915 B. Purpose for Submission: New device C. Measurand: Glycosylated hemoglobin (HbA1c) D. Type of Test: Quantitative Immunoassay E. Applicant: iXensor Co., LTD. F. Proprietary and Established Names: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit G. Regulatory Information: Classification Name Regulation Section Device Class Product Code Panel Assay, Glycosylated Hemoglobin 21 CFR 864.7470 II LCP Hematology (81) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 21CFR 862.2160 I JJE Chemistry (75) H. Intended Use: 1. Intended use(s): See indications for use below. 2 2. Indication(s) for use: The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates. 3. Special conditions for use statement(s): • For prescription use only. • This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels. • This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss. • For professional use in clinical laboratory and point-of-care settings. • This test is not intended for use in the diagnosis of or screening for diabetes. • This test is not intended for use on neonates. • For in-vitro diagnostic use only. • If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate. • Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants. • Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%). 4. Special instrument requirements: PixoTest POCT Analyzer I. Device Description: The iXensor PixoTest POCT System consists of the following components: 1) PixoTest POCT Analyzer, including • PixoHealth POCT A1c App • USB Charger • USB Type C Charge Cable • PixoTest POCT Calibration Card 3 • Instructions for Use 2) PixoTest POCT A1c Test Kit, including • PixoTest A1c Test Strips • Spoits (to acquire 5µl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c) • Buffer Solution Tubes • Instructions for Use J. Substantial Equivalence Information: 1. Predicate device name(s): SD A1cCare System and SD A1cCare Spoit Type Test Kit 2. Predicate 510(k) number(s): k140827 3. Comparison with predicate: Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Indications for Use Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. Same Test Principle Immunoassay Same Intended Use Environment Clinical laboratories and point-of-care settings Same Measuring Range 4.0-15.0% Same Sample Type Venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Fingerstick capillary or venous whole blood (anticoagulated with K2- EDTA, sodium heparin, lithium heparin, or sodium fluoride) Sample Volume 5 μL Same Sample Pretreatment tools Spoit, buffer tube Same 4 Similarities & Differences Item Device PixoTest POCT System (k181915) Predicate SD A1cCare System (k140827) Hematocrit 25-65% Same Calibration QR code with lot-specific calibration for associated test kits; calibration card for optical functional check Code chip with lot-specific calibration for associated test kits; check strip for optical functional check Quality Control Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2) available separately SD HbA1c Control Set (Level 1, Level 2), SD HbA1c Control Level M Storage Temperature 34-86°F (1-30°C) Same Maximum Altitude 3,000 m (9,843 feet) 2,000 m (6,560 feet) Operating Temperature 59-90°F (15-32°C) 59-104°F (15-40°C) Operating Humidity 10-90% relative humidity Same Shelf-Life of Test Strips 18 months Same Device Dimensions 181 x 111 x 53 (mm) 163 x 96 x 52 (mm) Device Weight 314.3 g 500 g Power supply 5000 mAh battery, non- removable, rechargeable 4x 1.5V AA Alkaline batteries or AC Adapter Memory Capacity >10000 tests results with date and time 900 tests results with date and time K. Standard/Guidance Document Referenced (if applicable): ISO 14971:2007, Medical devices - Application of risk management to medical devices ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements L. Test Principle: The PixoTest A1c Test kit uses an anti-HbA1c antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA1c is then immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample. The intensity of hemoglobin color from the 5 desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest POCT Analyzer. This system measures both fractions and uses an algorithm to convert the result into the percentage HbA1c in the sample. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: An internal precision study was performed with K2-EDTA venous whole blood samples containing five levels of HbA1c. Samples were tested in duplicate for two runs per day over 20 days using 1 test kit lot per analyzer for a total of 3 test kit lots and 3 analyzers. The results are shown below: HbA1c level (%) Lot N Mean HbA1c (%) Repeatability (Within-run) Between run Between day Total SD CV SD CV SD CV SD CV 4.0 to 5.5 1 80 5.27 0.17 3.1% 0.01 0.3% 0.12 2.2% 0.16 3.1% 2 80 5.17 0.15 2.8% 0.01 0.1% 0.11 2.0% 0.14 2.8% 3 80 5.25 0.20 3.8% 0.01 0.3% 0.16 3.0% 0.20 3.8% Combined 240 5.23 0.17 3.2% 0.01 0.2% 0.13 2.4% 0.17 3.3% 5.5 to 6.5 1 80 5.99 0.23 3.7% 0.01 0.2% 0.16 2.7% 0.22 3.7% 2 80 6.00 0.22 3.8% 0.01 0.2% 0.18 3.0% 0.22 3.7% 3 80 5.98 0.23 3. Proprietary and established names:

idK181915_s4000_e6000

K181915.txt

proposed labeling

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

System were compared to the HbA1c concentration assigned by TOSOH G7 method (k011434). The sponsor defined non- significant interference as < ± 6% change in HbA1c from the reference value. The data supports the claimed hemoglobin range of 7 to 23 g/dL. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: A method comparison study was conducted at three point of care sites with three intended use operators at each site. K2-EDTA venous whole blood samples from 120 subjects (40 subjects per site) were collectedand tested in singlicate with the PixoTest POCT System using three lots of PixoTest POCT A1c Test Kits at each site. The 9 results obtained with the PixoTest POCT System were compared to the results obtained for the same samples with the TOSOH G7 comparative method (k011434). The range of HbA1c tested was 4.6% to 14.2% HbA1c as determined by TOSOH G7 method. Results of the linear regression analysis are shown below. Site N HbA1c range (%) Slope Intercept R 1 40 4.6 – 13.4 0.988 0.157 0.987 2 40 5.0 – 13.3 1.054 -0.281 0.989 3 40 4.8 – 14.2 1.049 -0.242 0.991 Combined 120 4.6 – 14.2 1.024 -0.112 0.988 b. Matrix comparaison : Testing was performed to validate the use of venous whole blood samples with different anticoagulants with the PixoTest POCT System. Fifty venous whole blood samples (ranging from 5.0% to 13.0% HbA1c) were drawn into each of the intended anticoagulant tube types. Values for sodium heparin, lithium heparin, and sodium fluoride venous whole blood samples measured on PixoTest POCT System were compared to values obtained for K2-EDTA venous whole blood samples measured on PixoTest POCT System. Results of the linear regression analyses are shown below. Anticoagulant Slope Intercept R Sodium heparin 1.0192 -0.1801 0.9929 Lithium heparin 0.9983 0.0327 0.9907 Sodium fluoride 1.0146 -0.1055 0.9953 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. 10 5. Expected values/Reference range: The American Diabetes Association (ADA) recommended a reasonable A1c goal for many non-pregnant adults is < 7 % (53 mmol/mol). Providers might reasonably suggest more stringent A1C goals (such as 6.5 % [48 mmol/mol]) for selected individual patients if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Reference: American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan; 41 Suppl. 1: S55-S64. N. Instrument Name: PixoTest POCT Analyzer 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? Yes _______ or No ____X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes _______ or No ____X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: There is no specimen identification (other than the time stamp) for the PixoTest POCT system. 4. Specimen Sampling and Handling: This device is intended to be used with venous whole blood. Using the spoit, the venous whole blood sample will be mixed with the provided buffer and latex tablet first and then applied to the test strip. 11 5. Calibration: There is no calibration required by the user for the PixoTest POCT system. The meter must scan the corresponding QR Code, which stores the calibration information for each test kit lot, on the inside of the PixoTest A1c Test kit box prior to using a new lot. 6. Quality Control: iXensor does not provide control solutions. Users are recommended to check the accuracy of the meter using the Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2). The control solutions are sold separately. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable. 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:

idK181915_s4000_e6000

K181915.txt

conclusion

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

POCT System were compared to the HbA1c concentration assigned by TOSOH G7 method (k011434). The sponsor defined non- significant interference as < ± 6% change in HbA1c from the reference value. The data supports the claimed hemoglobin range of 7 to 23 g/dL. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: A method comparison study was conducted at three point of care sites with three intended use operators at each site. K2-EDTA venous whole blood samples from 120 subjects (40 subjects per site) were collectedand tested in singlicate with the PixoTest POCT System using three lots of PixoTest POCT A1c Test Kits at each site. The 9 results obtained with the PixoTest POCT System were compared to the results obtained for the same samples with the TOSOH G7 comparative method (k011434). The range of HbA1c tested was 4.6% to 14.2% HbA1c as determined by TOSOH G7 method. Results of the linear regression analysis are shown below. Site N HbA1c range (%) Slope Intercept R 1 40 4.6 – 13.4 0.988 0.157 0.987 2 40 5.0 – 13.3 1.054 -0.281 0.989 3 40 4.8 – 14.2 1.049 -0.242 0.991 Combined 120 4.6 – 14.2 1.024 -0.112 0.988 b. Matrix comparaison : Testing was performed to validate the use of venous whole blood samples with different anticoagulants with the PixoTest POCT System. Fifty venous whole blood samples (ranging from 5.0% to 13.0% HbA1c) were drawn into each of the intended anticoagulant tube types. Values for sodium heparin, lithium heparin, and sodium fluoride venous whole blood samples measured on PixoTest POCT System were compared to values obtained for K2-EDTA venous whole blood samples measured on PixoTest POCT System. Results of the linear regression analyses are shown below. Anticoagulant Slope Intercept R Sodium heparin 1.0192 -0.1801 0.9929 Lithium heparin 0.9983 0.0327 0.9907 Sodium fluoride 1.0146 -0.1055 0.9953 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. 10 5. Expected values/Reference range: The American Diabetes Association (ADA) recommended a reasonable A1c goal for many non-pregnant adults is < 7 % (53 mmol/mol). Providers might reasonably suggest more stringent A1C goals (such as 6.5 % [48 mmol/mol]) for selected individual patients if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Reference: American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan; 41 Suppl. 1: S55-S64. N. Instrument Name: PixoTest POCT Analyzer 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? Yes _______ or No ____X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes _______ or No ____X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: There is no specimen identification (other than the time stamp) for the PixoTest POCT system. 4. Specimen Sampling and Handling: This device is intended to be used with venous whole blood. Using the spoit, the venous whole blood sample will be mixed with the provided buffer and latex tablet first and then applied to the test strip. 11 5. Calibration: There is no calibration required by the user for the PixoTest POCT system. The meter must scan the corresponding QR Code, which stores the calibration information for each test kit lot, on the inside of the PixoTest A1c Test kit box prior to using a new lot. 6. Quality Control: iXensor does not provide control solutions. Users are recommended to check the accuracy of the meter using the Bio-Rad Liquicheck Diabetes Control (Level 1, Level 2). The control solutions are sold separately. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable. 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:

idK161619_s0_e2000

K161619.txt

purpose for submission

The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified.

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Purpose for submission:

idK161619_s0_e2000

K161619.txt

measurand

Trichomonas vaginalis (TV) DNA

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Measurand:

idK161619_s0_e2000

K161619.txt

type of test

Nucleic acid amplification test using real-time polymerase chain reaction (PCR)

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Type of test:

idK161619_s0_e2000

K161619.txt

classification

Class II

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Classification:

idK161619_s0_e2000

K161619.txt

panel

Microbiology (83)

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Panel:

idK161619_s0_e2000

K161619.txt

predicate device name

Cepheid Xpert TV assay

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Predicate device name:

idK161619_s0_e2000

K161619.txt

applicant

Cepheid

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Applicant:

idK161619_s0_e2000

K161619.txt

regulation section

21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161619 B. Purpose for Submission: The purpose of this submission is to add male urine specimens for use with the Xpert® Trichomonas vaginalis (TV) assay, which has already been cleared for female urine, endocervical swabs, and patient collected vaginal swabs under K151565. The original clinical study in K151565 included both male and female clinical specimens, but the male and female claims are addressed in two separate submissions. The male urine clinical data is submitted in the present file (K161619). All analytical studies on the urine specimen type were submitted and reviewed under K151565 unless otherwise specified. C. Measurand: Trichomonas vaginalis (TV) DNA D. Type of Test: Nucleic acid amplification test using real-time polymerase chain reaction (PCR) E. Applicant: Cepheid F. Proprietary and Established Names: Proprietary Name: Xpert® TV Common names: Xpert® TV assay, Xpert® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 1 21 CFR 866.3860, Trichomonas vaginalis nucleic acid assay 2. Classification: Class II 3. Product code: 2 OUY- Trichomonas vaginalis nucleic acid amplification test OOI- Real time nucleic acid amplification system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): 3 For prescription use only 4. Special instrument requirements: The Cepheid Xpert TV Assay uses PCR technology on the GeneXpert® Instrument Systems, which extract, amplify, and detect the target DNA I. Device Description: The Xpert TV Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of genomic DNA from Trichomonas vaginalis. The Xpert TV Assay is intended as an aid in the diagnosis of trichomoniasis. The Xpert TV Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System consists of an instrument, personal computer, and preloaded software for running tests and viewing the results. The GeneXpert Instrument System requires single-use, disposable cartridges (the Xpert TV cartridges) that hold the PCR reagents and host the PCR process. The cartridges are self-contained, so specimens never come into contact with the working parts of the instrument. A Sample Processing Control (SPC), Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System. The SPC is present to control for adequate processing of the target trichomonads and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability. The ancillary specimen collection kits for use with the Xpert TV Assay are the Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit and the Cepheid Xpert Urine Specimen Collection Kit. The swab and/or urine specimens are collected from asymptomatic or symptomatic patients and placed into a specimen transport tube containing preservative. After transferring the specimen to the sample chamber of the Xpert TV cartridge, the user initiates a test, and places the cartridge into the GeneXpert Instrument System. Results are automatically generated by the instrument at the end of the process in a report that can be viewed and printed. J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert TV assay 2. Predicate 510(k) number(s): 4 K151565 3. Comparison with predicate: Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Intended Use The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female and male urine specimens, endocervical swab specimens, and patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, The Cepheid Xpert TV Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection of Trichomonas vaginalis genomic DNA. The test utilizes automated real-time polymerase chain reaction (PCR) to detect Trichomonas vaginalis genomic DNA. The Xpert TV Assay uses female urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). The Xpert TV Assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals. Ancillary Collection Kits: Xpert Vaginal/Endocervical Specimen Collection Kit The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and 5 Similarities Item Subject Device: Cepheid Xpert TV Assay (K161619) Predicate Device: Cepheid Xpert TV Assay (K151565) Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay. Xpert Urine Specimen Collection Kit The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve Regulation section:

idK161619_s4000_e6000

K161619.txt

proposed labeling

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

iol f. Assay cut-off: The studies determining the assay cut-off were previously reviewed and described in K151565. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not Applicable 3. Clinical studies: 10 a. Clinical Sensitivity and Specificity: The clinical performance of the Xpert TV assay on female urine, endocervical swabs, and patient collected vaginal swabs has been previously reviewed under K151565. To assess the clinical performance characteristics of the Xpert TV assay on male urine, a multi- center prospective study was performed to collect urine specimens from asymptomatic males and males presenting with symptoms potentially associated with TV infection. The performance of the Xpert TV Assay was evaluated relative to a Patient Infected Status (PIS) algorithm. The designation of a subject as being infected was based on the results of the reference tests, which consisted of InPouch TV culture and validated bi-directional sequencing. A positive result from either of these two reference tests signified a TV positive subject. The subject was considered to be not infected when both reference test results were negative. The clinical study was performed between August 2014 and January 2015 and enrolled both male and female subjects. The clinical performance of the Xpert TV assay on the female specimen types (urine, endocervical swabs and patient-collected vaginal swabs) was previously reviewed and cleared in K151565. For the collection of male urine specimens, a total of 4465 male subjects were enrolled, of which 4458 were eligible for inclusion. The seven ineligible subjects included one subject with improper or incomplete informed consent, two subjects previously enrolled in the study, two subjects who had been treated with antibiotics within 21 days prior to study enrollment, one subject who was not sexually active, and one subject who was <14 years of age. The clinical study was extended for male subjects only between October 2015 and March 2016 at three of the original study sites. The inclusion/exclusion criteria, study procedures, enrollment, assay procedures, quality control, bias elimination, data collection and sample size calculations were the same as described in K151565. A total of 333 additional male subjects were enrolled and eligible for inclusion. A total of 4791 eligible male subjects (4458 from the original study and 333 subjects from the extended study) were enrolled. Of these, 165 were excluded due to 96 sample shipping delays, 36 samples tested more than 72 hours after collection, 21 Xpert modules out of calibration, and 12 samples not tested. This resulted in a total of 4626 specimens from eligible male subjects that were tested with the Xpert TV assay. Xpert TV results for 97.7% (4521/4626) of samples were successful on the first attempt; 105 results were indeterminate. One hundred of the 105 indeterminate samples were retested, and 90 of those cases yielded valid results. The overall rate of assay success was 99.7% (4611/4626). In total, 4611 specimens from male subjects were included in the clinical performance analysis (4626 eligible specimens tested minus 15 indeterminate results). Of these, 1088 were symptomatic and 3523 were asymptomatic. The average age of the male subjects was 36.2 years old, and the average age among symptomatic and asymptomatic subjects was 32.6 years and 37.4 years, respectively. The clinical performance of the Xpert TV assay was assessed for the original and supplemental studies both separately and combined. Analysis was performed using Fisher’s Exact p-value to ensure that no statistical difference was found between the results generated in the original and supplemental studies. The combined sensitivity for the urine specimen type was 87.5% and 90.3% for symptomatic and asymptomatic males, respectively. The overall sensitivity (including both symptomatic and asymptomatic subjects) was 89.6%. The combined specificity was 99.8% and 99.2% for symptomatic and asymptomatic males, respectively. The overall specificity (including both symptomatic and asymptomatic subjects) was 99.3%. The clinical performance data is reported in Table 2. Table 2: Xpert TV Assay clinical study results vs. PIS a: Testing results by additional sequencing: 10 of 13 false negatives were TV negative; 3 of 13 were TV positive b: Testing results by additional sequencing: 27 of 31 false positives were TV positive; 4 of 31 were TV negative 4. Clinical cut-off: 11 Not applicable 5. Expected values/Reference range: The estimated positive predictive value (PPV) and negative predictive value (NPV) of the Xpert TV Assay across different hypothetical prevalence rates are shown for the male urine specimen type in Table 3. (The expected values for female urine, endocervical swabs, and vaginal swabs are reported in K151565). These calculations are based on the overall estimated sensitivity and specificity observed for male urine specimens during the Xpert TV multi-center clinical study. The overall sensitivity and specificity for male urine (UR) was 89.6% and 99.3%, respectively. Collection Status Total (n) Sensitivity 95% CI Specificity 95% CI Prev (%) PPV (%) NPV (%) Combined Study Symp 1088 87.5% (28/32) 71.9%-95.0% 99.8% (1054/1056) 99.3%-99.9% 2.9% 93.3% 99.6% Asymp 3523 90.3% (84/93) 82.6%-94.8% 99.2% (3401/3430) 98.8%-99.4% 2.6% 74.3% 99.7% Overall 4611 89.6% (112/125)a 83.0%-93.8% 99.3% (4455/4486)b 99.0%-99.5% 2.7% 78.3% 99.7% Table 3: Hypothetical PPV and NPV of the Xpert TV assay 12 Specimen Type Prevalence (%) PPV (%) NPV (%) Male UR 1 56.7% 99.9% 2 72.6% 99.8% 5 87.2% 99.5% 10 93.5% 98.9% 12 94.6% 98.6% 15 95.8% 98.2% 20 97.0% 97.4% 25 97.7% 96.6% N. Instrument Name: GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity- 48s and GeneXpertInfinity-80 systems). 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? Yes ________ or No ____X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: The user can scan or type the patient ID. 4. Specimen Sampling and Handling: Male urine is collected and tested using the Xpert urine collection kit. First-catch urine is collected in a urine collection cup free of any preservatives. A disposable pipet is used to transfer approximately 7 mL of urine into the Xpert urine transport reagent tube. The tube is capped and inverted 3-4 times to ensure mixing. 5. Calibration: 13 The user is instructed to contact Cepheid regarding instrument calibration in each operator manual. 6. Quality Control: The Xpert TV assay includes a sample adequacy control to verify that human DNA is present in the sample, a sample processing control to verify adequate processing of sample, and a probe check control to ensure adequate reagent rehydration. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable 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:

idK161619_s4000_e6000

K161619.txt

conclusion

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

stradiol f. Assay cut-off: The studies determining the assay cut-off were previously reviewed and described in K151565. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not Applicable 3. Clinical studies: 10 a. Clinical Sensitivity and Specificity: The clinical performance of the Xpert TV assay on female urine, endocervical swabs, and patient collected vaginal swabs has been previously reviewed under K151565. To assess the clinical performance characteristics of the Xpert TV assay on male urine, a multi- center prospective study was performed to collect urine specimens from asymptomatic males and males presenting with symptoms potentially associated with TV infection. The performance of the Xpert TV Assay was evaluated relative to a Patient Infected Status (PIS) algorithm. The designation of a subject as being infected was based on the results of the reference tests, which consisted of InPouch TV culture and validated bi-directional sequencing. A positive result from either of these two reference tests signified a TV positive subject. The subject was considered to be not infected when both reference test results were negative. The clinical study was performed between August 2014 and January 2015 and enrolled both male and female subjects. The clinical performance of the Xpert TV assay on the female specimen types (urine, endocervical swabs and patient-collected vaginal swabs) was previously reviewed and cleared in K151565. For the collection of male urine specimens, a total of 4465 male subjects were enrolled, of which 4458 were eligible for inclusion. The seven ineligible subjects included one subject with improper or incomplete informed consent, two subjects previously enrolled in the study, two subjects who had been treated with antibiotics within 21 days prior to study enrollment, one subject who was not sexually active, and one subject who was <14 years of age. The clinical study was extended for male subjects only between October 2015 and March 2016 at three of the original study sites. The inclusion/exclusion criteria, study procedures, enrollment, assay procedures, quality control, bias elimination, data collection and sample size calculations were the same as described in K151565. A total of 333 additional male subjects were enrolled and eligible for inclusion. A total of 4791 eligible male subjects (4458 from the original study and 333 subjects from the extended study) were enrolled. Of these, 165 were excluded due to 96 sample shipping delays, 36 samples tested more than 72 hours after collection, 21 Xpert modules out of calibration, and 12 samples not tested. This resulted in a total of 4626 specimens from eligible male subjects that were tested with the Xpert TV assay. Xpert TV results for 97.7% (4521/4626) of samples were successful on the first attempt; 105 results were indeterminate. One hundred of the 105 indeterminate samples were retested, and 90 of those cases yielded valid results. The overall rate of assay success was 99.7% (4611/4626). In total, 4611 specimens from male subjects were included in the clinical performance analysis (4626 eligible specimens tested minus 15 indeterminate results). Of these, 1088 were symptomatic and 3523 were asymptomatic. The average age of the male subjects was 36.2 years old, and the average age among symptomatic and asymptomatic subjects was 32.6 years and 37.4 years, respectively. The clinical performance of the Xpert TV assay was assessed for the original and supplemental studies both separately and combined. Analysis was performed using Fisher’s Exact p-value to ensure that no statistical difference was found between the results generated in the original and supplemental studies. The combined sensitivity for the urine specimen type was 87.5% and 90.3% for symptomatic and asymptomatic males, respectively. The overall sensitivity (including both symptomatic and asymptomatic subjects) was 89.6%. The combined specificity was 99.8% and 99.2% for symptomatic and asymptomatic males, respectively. The overall specificity (including both symptomatic and asymptomatic subjects) was 99.3%. The clinical performance data is reported in Table 2. Table 2: Xpert TV Assay clinical study results vs. PIS a: Testing results by additional sequencing: 10 of 13 false negatives were TV negative; 3 of 13 were TV positive b: Testing results by additional sequencing: 27 of 31 false positives were TV positive; 4 of 31 were TV negative 4. Clinical cut-off: 11 Not applicable 5. Expected values/Reference range: The estimated positive predictive value (PPV) and negative predictive value (NPV) of the Xpert TV Assay across different hypothetical prevalence rates are shown for the male urine specimen type in Table 3. (The expected values for female urine, endocervical swabs, and vaginal swabs are reported in K151565). These calculations are based on the overall estimated sensitivity and specificity observed for male urine specimens during the Xpert TV multi-center clinical study. The overall sensitivity and specificity for male urine (UR) was 89.6% and 99.3%, respectively. Collection Status Total (n) Sensitivity 95% CI Specificity 95% CI Prev (%) PPV (%) NPV (%) Combined Study Symp 1088 87.5% (28/32) 71.9%-95.0% 99.8% (1054/1056) 99.3%-99.9% 2.9% 93.3% 99.6% Asymp 3523 90.3% (84/93) 82.6%-94.8% 99.2% (3401/3430) 98.8%-99.4% 2.6% 74.3% 99.7% Overall 4611 89.6% (112/125)a 83.0%-93.8% 99.3% (4455/4486)b 99.0%-99.5% 2.7% 78.3% 99.7% Table 3: Hypothetical PPV and NPV of the Xpert TV assay 12 Specimen Type Prevalence (%) PPV (%) NPV (%) Male UR 1 56.7% 99.9% 2 72.6% 99.8% 5 87.2% 99.5% 10 93.5% 98.9% 12 94.6% 98.6% 15 95.8% 98.2% 20 97.0% 97.4% 25 97.7% 96.6% N. Instrument Name: GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity- 48s and GeneXpertInfinity-80 systems). 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? Yes ________ or No ____X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: The user can scan or type the patient ID. 4. Specimen Sampling and Handling: Male urine is collected and tested using the Xpert urine collection kit. First-catch urine is collected in a urine collection cup free of any preservatives. A disposable pipet is used to transfer approximately 7 mL of urine into the Xpert urine transport reagent tube. The tube is capped and inverted 3-4 times to ensure mixing. 5. Calibration: 13 The user is instructed to contact Cepheid regarding instrument calibration in each operator manual. 6. Quality Control: The Xpert TV assay includes a sample adequacy control to verify that human DNA is present in the sample, a sample processing control to verify adequate processing of sample, and a probe check control to ensure adequate reagent rehydration. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable 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:

idK161619_s4000_e6000

K161619.txt

applicant

Cepheid

adiol f. Assay cut-off: The studies determining the assay cut-off were previously reviewed and described in K151565. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not Applicable 3. Clinical studies: 10 a. Clinical Sensitivity and Specificity: The clinical performance of the Xpert TV assay on female urine, endocervical swabs, and patient collected vaginal swabs has been previously reviewed under K151565. To assess the clinical performance characteristics of the Xpert TV assay on male urine, a multi- center prospective study was performed to collect urine specimens from asymptomatic males and males presenting with symptoms potentially associated with TV infection. The performance of the Xpert TV Assay was evaluated relative to a Patient Infected Status (PIS) algorithm. The designation of a subject as being infected was based on the results of the reference tests, which consisted of InPouch TV culture and validated bi-directional sequencing. A positive result from either of these two reference tests signified a TV positive subject. The subject was considered to be not infected when both reference test results were negative. The clinical study was performed between August 2014 and January 2015 and enrolled both male and female subjects. The clinical performance of the Xpert TV assay on the female specimen types (urine, endocervical swabs and patient-collected vaginal swabs) was previously reviewed and cleared in K151565. For the collection of male urine specimens, a total of 4465 male subjects were enrolled, of which 4458 were eligible for inclusion. The seven ineligible subjects included one subject with improper or incomplete informed consent, two subjects previously enrolled in the study, two subjects who had been treated with antibiotics within 21 days prior to study enrollment, one subject who was not sexually active, and one subject who was <14 years of age. The clinical study was extended for male subjects only between October 2015 and March 2016 at three of the original study sites. The inclusion/exclusion criteria, study procedures, enrollment, assay procedures, quality control, bias elimination, data collection and sample size calculations were the same as described in K151565. A total of 333 additional male subjects were enrolled and eligible for inclusion. A total of 4791 eligible male subjects (4458 from the original study and 333 subjects from the extended study) were enrolled. Of these, 165 were excluded due to 96 sample shipping delays, 36 samples tested more than 72 hours after collection, 21 Xpert modules out of calibration, and 12 samples not tested. This resulted in a total of 4626 specimens from eligible male subjects that were tested with the Xpert TV assay. Xpert TV results for 97.7% (4521/4626) of samples were successful on the first attempt; 105 results were indeterminate. One hundred of the 105 indeterminate samples were retested, and 90 of those cases yielded valid results. The overall rate of assay success was 99.7% (4611/4626). In total, 4611 specimens from male subjects were included in the clinical performance analysis (4626 eligible specimens tested minus 15 indeterminate results). Of these, 1088 were symptomatic and 3523 were asymptomatic. The average age of the male subjects was 36.2 years old, and the average age among symptomatic and asymptomatic subjects was 32.6 years and 37.4 years, respectively. The clinical performance of the Xpert TV assay was assessed for the original and supplemental studies both separately and combined. Analysis was performed using Fisher’s Exact p-value to ensure that no statistical difference was found between the results generated in the original and supplemental studies. The combined sensitivity for the urine specimen type was 87.5% and 90.3% for symptomatic and asymptomatic males, respectively. The overall sensitivity (including both symptomatic and asymptomatic subjects) was 89.6%. The combined specificity was 99.8% and 99.2% for symptomatic and asymptomatic males, respectively. The overall specificity (including both symptomatic and asymptomatic subjects) was 99.3%. The clinical performance data is reported in Table 2. Table 2: Xpert TV Assay clinical study results vs. PIS a: Testing results by additional sequencing: 10 of 13 false negatives were TV negative; 3 of 13 were TV positive b: Testing results by additional sequencing: 27 of 31 false positives were TV positive; 4 of 31 were TV negative 4. Clinical cut-off: 11 Not applicable 5. Expected values/Reference range: The estimated positive predictive value (PPV) and negative predictive value (NPV) of the Xpert TV Assay across different hypothetical prevalence rates are shown for the male urine specimen type in Table 3. (The expected values for female urine, endocervical swabs, and vaginal swabs are reported in K151565). These calculations are based on the overall estimated sensitivity and specificity observed for male urine specimens during the Xpert TV multi-center clinical study. The overall sensitivity and specificity for male urine (UR) was 89.6% and 99.3%, respectively. Collection Status Total (n) Sensitivity 95% CI Specificity 95% CI Prev (%) PPV (%) NPV (%) Combined Study Symp 1088 87.5% (28/32) 71.9%-95.0% 99.8% (1054/1056) 99.3%-99.9% 2.9% 93.3% 99.6% Asymp 3523 90.3% (84/93) 82.6%-94.8% 99.2% (3401/3430) 98.8%-99.4% 2.6% 74.3% 99.7% Overall 4611 89.6% (112/125)a 83.0%-93.8% 99.3% (4455/4486)b 99.0%-99.5% 2.7% 78.3% 99.7% Table 3: Hypothetical PPV and NPV of the Xpert TV assay 12 Specimen Type Prevalence (%) PPV (%) NPV (%) Male UR 1 56.7% 99.9% 2 72.6% 99.8% 5 87.2% 99.5% 10 93.5% 98.9% 12 94.6% 98.6% 15 95.8% 98.2% 20 97.0% 97.4% 25 97.7% 96.6% N. Instrument Name: GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity- 48s and GeneXpertInfinity-80 systems). 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? Yes ________ or No ____X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ____X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____X____ or No ________ 3. Specimen Identification: The user can scan or type the patient ID. 4. Specimen Sampling and Handling: Male urine is collected and tested using the Xpert urine collection kit. First-catch urine is collected in a urine collection cup free of any preservatives. A disposable pipet is used to transfer approximately 7 mL of urine into the Xpert urine transport reagent tube. The tube is capped and inverted 3-4 times to ensure mixing. 5. Calibration: 13 The user is instructed to contact Cepheid regarding instrument calibration in each operator manual. 6. Quality Control: The Xpert TV assay includes a sample adequacy control to verify that human DNA is present in the sample, a sample processing control to verify adequate processing of sample, and a probe check control to ensure adequate reagent rehydration. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable 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. Applicant:

idK162895_s0_e2000

K162895.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Purpose for submission:

idK162895_s0_e2000

K162895.txt

measurand

Cardiac troponin T (cTnT)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Measurand:

idK162895_s0_e2000

K162895.txt

type of test

Quantitative immunoassay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Type of test:

idK162895_s0_e2000

K162895.txt

panel

Chemistry

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Panel:

idK162895_s0_e2000

K162895.txt

intended use

See Indication(s) for use.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Intended use:

idK162895_s0_e2000

K162895.txt

predicate device name

Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Predicate device name:

idK162895_s0_e2000

K162895.txt

applicant

Roche Diagnostics

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K162895 B. Purpose for Submission: New device C. Measurand: Cardiac troponin T (cTnT) D. Type of Test: Quantitative immunoassay E. Applicant: Roche Diagnostics F. Proprietary and Established Names: Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T Gen 5 STAT CalSet Elecsys PreciControl Troponin Elecsys Troponin T Gen 5 CalCheck 5 G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Chemistry JIT Class II 21 CFR 862.1150 - Calibrator JJX Class I, Reserved 21 CFR 862.1660 - Quality control material (assayed and unassayed) JJY H. Intended Use: 1. Intended use(s): See Indication(s) for use. 2. Indication(s) for use: Elecsys Troponin T Gen 5 STAT Immunoassay Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. 2 Elecsys Troponin T Gen 5 STAT CalSet The Troponin T Gen 5 STAT CalSet is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. Elecsys PreciControl Troponin PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT Immunoassay on the cobas system analyzers. Elecsys Troponin T Gen 5 CalCheck 5 The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers. 3. Special conditions for use statement(s): • For prescription use • For in vitro diagnostic use • The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Please refer to the Analytical specificity section in M.1.e. below for additional limitations. 4. Special instrument requirements: Performance data for this submission were generated using the cobas e 411 and cobas e 601 analyzers. I. Device Description: Elecsys Troponin T Gen 5 STAT Immunoassay: The reagents are: M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-cardiac troponin T‑antibody (mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative; inhibitors. R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal chimeric anti‑cardiac troponin T‑antibody (mouse/human) labeled with ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative. The Elecsys Troponin T Gen 5 STAT CalSet is a lyophilized product consisting of human serum with cardiac troponin T at two concentrations (approximately 18 ng/L or pg/mL and approximately 4200 ng/L or pg/mL). 2+ 3 3 The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added troponin T (recombinant, human) and Troponin I (recombinant, human) at two concentrations. The concentrations of cardiac Troponin T are approximately 30 ng/L or pg/mL and approximately 2500 ng/L or pg/mL. This control material was initially cleared in k082699 as assayed quality control material for other analytes. The Elecsys Troponin T Gen 5 CalCheck 5 contains 5 lyophilized levels of human recombinant cardiac troponin T in human serum in the following concentrations: Level Approximate Target Range (ng/L) Check 1 ≤ 5.0 Check 2 10.5 – 19.5 Check 3 1460 - 2540 Check 4 5840 - >10000 Check 5 7300 - >10000 The labeling states “All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.” J. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys Troponin T STAT Assay, Elecsys Troponin T CalSet, Elecsys PreciControl Troponin, Elecsys CA 15-3 CalCheck 5 2. Predicate 510(k) number(s): K051752, K961500, K082699, K122242 4 3. Comparison with predicate: Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Similarities Indications for use Immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. Same Analyte Cardiac troponin T Same Type of immunoassay Sandwich immunoassay Same Detection technology Electrochemiluminescence Same Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Indications for use Not indicated for these uses Indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. Cut-off for the aid in the diagnosis of myocardial infarction 19 ng/L for both sexes based on the 99th percentile upper reference limit of apparently healthy males and females. 14 ng/L for females based on the 99th percentile upper reference limit of apparently healthy females and 22 ng/L for males based on the 99th percentile upper reference limit of apparently healthy males. 0.1 ng/mL based on ROC analysis 5 Item Elecsys Troponin T Gen 5 STAT Immunoassay Elecsys Troponin T STAT Assay (K051752) Differences Type of specimen Lithium heparin plasma Plasma and serum Assay range 6.0 -10000 ng/L 0.01 – 25.0 ng/mL Item Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T CalSet (K961500) Similarities Intended use Intended for use in the calibration of a troponin assay Same Differences Troponin T concentrations 2 levels (18 and 4200 ng/L) 2 Levels (0.075 and 10 ng/mL) Item Elecsys PreciControl Troponin Elecsys PreciControl Troponin (K082699) Similarities Intended use Intended for use in the quality control of a troponin assay Same Differences Analyte Troponin T and Troponin I Troponin I Item Elecsys Troponin T Gen 5 CalCheck 5 Elecsys CA 15-3 CalCheck 5 (K122242) Similarities Intended use Intended for calibration verification and for verification of the assay range Same Differences Analyte 5 levels of troponin T (< 5 ng/L – 10000 ng/L) 5 Levels of CA 15-3 (1.58 – 300 U/mL) K. Standard/Guidance Document Referenced (if applicable): Clinical and Laboratory Standards Institute (CLSI) EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Applicant:

idK162895_s8000_e10000

K162895.txt

proposed labeling

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

97.1- 99.8 The following limitation is included in the labeling: The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Males using the 22 ng/L cut-off Time- point n Sensitivity Specificity PPV NPV % 95% CI % 95% CI % 95% CI % 95% CI Baseline 841 86.3 (88/ 102) 78- 92.3 87.3 (645/ 739) 84.7- 89.6 48.4 (88/ 182) 40.9- 55.9 97.9 (645/ 659) 96.5- 98.8 3 hours 742 95.7 (88/92) 89.2- 98.8 85.7 (557/ 650) 82.8- 88.3 48.6 (88/ 181) 41.1- 56.1 99.3 (557/ 561) 98.2- 99.8 6 -9 hours 625 93.3 (84/90) 86.1- 97.5 82.1 (439/ 535) 78.5- 85.2 46.7 (84/ 180) 39.2- 54.2 98.7 (439/ 445) 97.1- 99.5 12-24 hours 477 94.5 (69/73) 86.6- 98.5 80.2 (324/ 404) 76- 84 46.3 (69/ 149) 38.1- 54.7 98.8 (324/ 328) 96.9- 99.7 The sponsor includes the following information in the package insert about troponin in other disease states: 17 Troponins are released during the process of myocyte necrosis. While they are cardiac specific, they are not specific for MI and detectable levels may be seen in other disease states that involve the heart muscle (e.g. arrhythmia, acute aortic syndrome, acute heart failure, hypertensive crisis, myocarditis, pericarditis, pulmonary embolism and Takotsubo cardiomyopathy), so that ACC/ESC/AHA guidelines and the Universal Definition of MI recommend serial sampling with a rise or fall in troponin to distinguish between acute and chronic cTn elevations. Results should be interpreted in conjunction with clinical presentation including medical history, signs and symptoms, ECG data and biomarker concentrations. b. Clinical specificity: See section M.3.a. Clinical sensitivity above. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: This assay has 3 claimed cut-offs. These are overall (19 ng/L), a cut-off for females (14 ng/L), and a cut-off for males (22 ng/L) all of which were determined using the 99th percentile upper reference limit. 5. Expected values/Reference range: To establish the 99th percentile upper reference limit in lithium heparin plasma samples, a reference range study was conducted at 4 external collection sites in a population of apparently healthy adults. In order to capture an apparently healthy population, subjects were excluded if they had a diagnosis of cancer, or any chronic disease, were taking prescriptions for a chronic diseases, had high blood pressure, had a history of acute coronary syndrome, had been hospitalized within the last 3 months, and was pregnant or had delivered a baby within the last 6 weeks. The study population of 1301 included 645 males and 656 females. The 99th percentile upper reference limit was demonstrated to be 19 ng/L overall, 14 ng/L for females, and 22 ng/L for males. 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:

idK162895_s8000_e10000

K162895.txt

conclusion

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

299) 97.1- 99.8 The following limitation is included in the labeling: The positive predictive value for females using the lower sex-specific cut-off (14 ng/L) is lower when compared to the higher cut-off of 19 ng/L. When looking at the lower bound of the 95% CI, up to 69%, 82% and 78% of positive test results for females are non-MI. Troponin results should always be used in conjunction with clinical signs and symptoms. Males using the 22 ng/L cut-off Time- point n Sensitivity Specificity PPV NPV % 95% CI % 95% CI % 95% CI % 95% CI Baseline 841 86.3 (88/ 102) 78- 92.3 87.3 (645/ 739) 84.7- 89.6 48.4 (88/ 182) 40.9- 55.9 97.9 (645/ 659) 96.5- 98.8 3 hours 742 95.7 (88/92) 89.2- 98.8 85.7 (557/ 650) 82.8- 88.3 48.6 (88/ 181) 41.1- 56.1 99.3 (557/ 561) 98.2- 99.8 6 -9 hours 625 93.3 (84/90) 86.1- 97.5 82.1 (439/ 535) 78.5- 85.2 46.7 (84/ 180) 39.2- 54.2 98.7 (439/ 445) 97.1- 99.5 12-24 hours 477 94.5 (69/73) 86.6- 98.5 80.2 (324/ 404) 76- 84 46.3 (69/ 149) 38.1- 54.7 98.8 (324/ 328) 96.9- 99.7 The sponsor includes the following information in the package insert about troponin in other disease states: 17 Troponins are released during the process of myocyte necrosis. While they are cardiac specific, they are not specific for MI and detectable levels may be seen in other disease states that involve the heart muscle (e.g. arrhythmia, acute aortic syndrome, acute heart failure, hypertensive crisis, myocarditis, pericarditis, pulmonary embolism and Takotsubo cardiomyopathy), so that ACC/ESC/AHA guidelines and the Universal Definition of MI recommend serial sampling with a rise or fall in troponin to distinguish between acute and chronic cTn elevations. Results should be interpreted in conjunction with clinical presentation including medical history, signs and symptoms, ECG data and biomarker concentrations. b. Clinical specificity: See section M.3.a. Clinical sensitivity above. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: This assay has 3 claimed cut-offs. These are overall (19 ng/L), a cut-off for females (14 ng/L), and a cut-off for males (22 ng/L) all of which were determined using the 99th percentile upper reference limit. 5. Expected values/Reference range: To establish the 99th percentile upper reference limit in lithium heparin plasma samples, a reference range study was conducted at 4 external collection sites in a population of apparently healthy adults. In order to capture an apparently healthy population, subjects were excluded if they had a diagnosis of cancer, or any chronic disease, were taking prescriptions for a chronic diseases, had high blood pressure, had a history of acute coronary syndrome, had been hospitalized within the last 3 months, and was pregnant or had delivered a baby within the last 6 weeks. The study population of 1301 included 645 males and 656 females. The 99th percentile upper reference limit was demonstrated to be 19 ng/L overall, 14 ng/L for females, and 22 ng/L for males. 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:

idK181092_s0_e2000

K181092.txt

purpose for submission

To obtain a substantial equivalence determination for the CHROMID CARBA Agar

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Purpose for submission:

idK181092_s0_e2000

K181092.txt

measurand

Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Measurand:

idK181092_s0_e2000

K181092.txt

type of test

Selective and differential culture medium

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Type of test:

idK181092_s0_e2000

K181092.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Classification:

idK181092_s0_e2000

K181092.txt

product code

JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Product code:

idK181092_s0_e2000

K181092.txt

panel

83: Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Panel:

idK181092_s0_e2000

K181092.txt

predicate device name

bioMérieux CHROMID VRE agar

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Predicate device name:

idK181092_s0_e2000

K181092.txt

applicant

bioMérieux SA

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Applicant:

idK181092_s0_e2000

K181092.txt

proprietary and established names

CHROMID CARBA agar (CARB)

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Proprietary and established names:

idK181092_s0_e2000

K181092.txt

regulation section

21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K181092 B. Purpose for Submission: To obtain a substantial equivalence determination for the CHROMID CARBA Agar C. Measurand: Colonies of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae D. Type of Test: Selective and differential culture medium E. Applicant: bioMérieux SA F. Proprietary and Established Names: CHROMID CARBA agar (CARB) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests 2. Classification: Class II 3. Product code: JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar 4. Panel: 83: Microbiology 2 H. Intended Use: 1. Intended use(s): CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase- producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only. A lack of growth or the absence of pink-burgundy or blue-green/blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Based on analytical studies, high concentrations (≥108 CFU/mL) of carbapenemase- producing E. cloacae, M. morganii and P. aeruginosa may inhibit or mask the growth of low levels of carbapenemase-producing E. coli. In addition, high concentrations (≥108 CFU/mL) of carbapenemase-producing E. coli and M. morganii may inhibit or mask the growth of low levels of carbapenemase-producing K. pneumoniae. Additional testing by an alternative method (e.g., enrichment broth culture) is required if a negative result is obtained with CHROMID CARBA agar and carriage of carbapenemase-producing E. coli or K. pneumoniae is suspected. Performance of CHROMID CARBA agar was established for carbapenemase-producing E. coli and K. pneumoniae that carry K. pneumoniae Carbapenemase (KPC). 3 Performance with Carbapenemase-producing Enterobacteriaceae (CPE) other than E. coli and K. pneumoniae and other types of carbapenemase enzyme has not been established. Organisms producing the following non-KPC carbapenemase enzymes may grow and produce pink to burgundy or blue-green to blue-grey pigmented colonies after 18 to 24 hours on CHROMID CARBA agar: IMP, NDM, OXA-48, SME and VIM. Some carbapenem non-susceptible organisms that do not produce carbapenemase but which exhibit other resistance mechanisms may grow on CHROMID CARBA agar and produce blue-green to blue-grey or pink to burgundy pigmented colonies after 18 to 24 hours. Sub-culture to non-selective medium is required to for organism identification, antimicrobial susceptibility testing and confirmation of carbapenemase production. 4. Special instrument requirements: None I. Device Description: CHROMID CARBA agar is a selective and differential culture medium that contains a combination of antimicrobial agents and chromogenic substrates. The medium is intended for use in screening of rectal swab specimens for the presence of carbapenemase-producing E. coli and K. pneumoniae. Presumptive carbapenemase-producing colonies of E. coli appear pink-burgundy whereas those of K. pneumoniae appear blue-green/blue-grey. All isolates must be sub-cultured for identification, antimicrobial susceptibility testing and confirmation of carbapenemase production, as well as epidemiological typing (if required). J. Substantial Equivalence Information: 1. Predicate device name(s): bioMérieux CHROMID VRE agar 2. Predicate 510(k) number(s): K091025 4 3. Comparison with predicate: Similarities Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Intended Use CHROMID CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID CARBA agar with colonies that appear pink to burgundy or blue- green to blue-grey. Sub- CHROMID VRE agar is a selective and differential chromogenic medium containing 8 µg/mL vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. CHROMlD VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. CHROMlD VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. 5 Differences Item Device Predicate CHROMID CARBA agar (K181092) CHROMID VRE agar (K091025) Specimen Type Rectal swab Stool Target Species, Resistance Mechanisms and Associated Colony Colors Carbapenemase-producing E. coli (pink-burgundy) and K. pneumoniae (blue- green/blue-grey) Vancomycin-resistant E. faecium (violet) and E. faecalis (blue-green) Incubation Time 18-24 hours 24-48 hours K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; August 28, 2009. culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms. Technology Selective, differential chromogenic culture medium Same Inoculation Direct specimen Same Interpretation Manual, visual Same Results Presumptive Same Subculture Required for confirmation of organism identity and antimicrobial susceptibility testing Same 6 CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017. L. Test Principle: CHROMID CARBA agar consists of nutritive medium containing peptones and a mixture of antimicrobial agents that select for growth of carbapenemase-producing Enterobacteriaceae (CPE), and chromogenic substrates that enable presumptive identification of the most common carbapenemase-producing species. Colonies of carbapenemase-producing E. coli appear pink-burgundy due to the production of b-glucuronidase or b-galactos Regulation section:

idK181092_s10000_e12000

K181092.txt

proposed labeling

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

Table 7. A summary of the isolates tested is shown in Table 10. Each contrived specimen was spiked with a unique bacterial strain at a concentration equivalent to 1-10X the analytical LoD of the CHROMID CARBA agar (Section M(1)(d)). Testing was performed in a blinded fashion at four different sites. A summary of the results obtained on CHROMID CARBA agar in comparison to the expected organism identity and Carbapenemase Status is provided in Tables 11 (a) & (b). 20 Table 10. Isolates included in the Contrived Specimen Study Species Number of Isolates Tested Carbapenemase Status Positive Negative Citrobacter freundii 1 1 0 Enterobacter cloacae 4 4 0 Escherichia coli 38 20 1 18 Klebsiella oxytoca 1 1 0 Klebsiella ozaenae 1 1 0 Klebsiella pneumoniae 160 88 2 72 Kluyvera ascorbata 1 1 0 Morganella morganii 1 1 0 Proteus mirabilis 2 2 0 Raoultella ornithinolytica 1 1 0 Total 210 120 3 90 1 blaKPC: 11 (KPC-2: 9, KPC-3: 2); blaNDM: 4; blaOXA-48: 2; blaVIM: 2; blaIMP: 1 2 blaKPC: 77 (45 KPC-3, 30 KPC-2, 2 other variants); blaVIM: 4; blaNDM: 3; blaIMP: 2; blaOXA-48: 2 3 Overall, 110/120 isolates (92%) were positive for blaKPC, including 12/12 isolates (100%) of species other than E. coli and K. pneumoniae 21 Tables 11(a) & (b). Contrived Specimen Study: CHROMID CARBA agar Colony Color vs Expected Organism Identity and Carbapenemase Status Table 11(a): Carbapenemase-producing E. coli Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 16 2 3 18 Negative 2 4 4 188 192 Total 20 190 210 Positive Percent Agreement 80.0% (16/20); 58.4-91.9% Negative Percent Agreement 98.9% (188/190); 95% CI 96.2-99.7% 95% CI: 95% score confidence interval 1 Pink-burgundy colonies 2 No growth or colonies not pink-burgundy 3 2/2 isolates were carbapenem non-susceptible E. coli (resistant to meropenem and ertapenem and an intermediate MIC for imipenem); both isolates were positive for Extended Spectrum b-Lactamase (ESBL) 4 False negative results were obtained with 4 strains of carbapenem non-susceptible E. coli that harbored blaOXA-48 (2), blaNDM (1) and blaVIM (1) and which were spiked at target levels ranging from 1X to 10X LoD; 2/4 strains had an intermediate MIC to at least one carbapenem including 1 strain that was also susceptible to ertapenem Table 11(b): Carbapenemase-producing K. pneumoniae Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 84 11 3, 4 95 Negative 2 3 5 112 6 115 Total 87 123 210 Positive Percent Agreement 96.6% (84/87); 95% CI % 90.3-98.8% Negative Percent Agreement 91.1% (112/123); 95% CI 84.7-94.9% 95% CI: 95% score confidence interval 1 Blue-green/blue-grey colonies 2 No growth or colonies not blue-green/blue-grey 3 5/11 false positive results were obtained with carbapenem non-susceptible K. pneumoniae, all of which were positive for ESBL (3) or ESBL and AmpC (2) 4 6/11 false positive results were due to Carbapenemase Status-positive species of Enterobacteriaceae other than K. pneumoniae that harbored blaKPC: E. cloacae (4), K. oxytoca (1) and K. ozaenae (1) 5 3/3 false negative results were obtained with Carbapenemase Status positive isolates at the LoD target level; each strain carried a different carbapenemase resistance marker (blaIMP (1), blaKPC (1) or blaOXA-48 (1)); 2/3 strains had a susceptible or intermediate MIC to at least one of the three carbapenems tested (ertapenem, imipenem or meropenem) 6 18/112 samples contained carbapenem non-susceptible strains of K. pneumoniae of which 17 were phenotypically carbapenemase negative; 11/18 were positive for ESBL and 6/18 were positive for AmpC Challenge Study To supplement the results of the Prospective Clinical Study and Contrived Specimen Study, additional testing was performed using well characterized Carbapenemase Status-positive and -negative isolates of E. coli and K. pneumoniae that were suspended in saline at 3 x 103 CFU/mL (equivalent to 2X LoD [Section M(1)(d)]). Included in the study were strains with known blaKPC variants (KPC-2 [12], KPC-3 22 [18] and KPC-4 [1]). Samples were blinded and tested at one study site. A summary of the results is provided in Tables 12 (a) & (b). Table 12 (a) & (b). Challenge Study: CHROMID CARBA agar Colony Color vs Expected Organism Identity and Carbapenemase Status Table 12(a): Carbapenemase-producing E. coli Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 12 3 0 12 Negative 2 0 38 38 Total 12 38 50 Positive Percent Agreement 100% (12/12); 75.8-100% Negative Percent Agreement 100% (38/38); 95% CI 90.8-100% 95% CI: 95% score confidence interval 1 Pink-burgundy colonies 2 No growth or colonies not pink-burgundy 3 Includes strains of E. coli known to carry the following blaKPC variants: KPC-2: 1; KPC-3: 3; KPC-4: 1 Table 12(b): Carbapenemase-producing K. pneumoniae Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 27 3 0 27 Negative 2 0 23 23 Total 27 23 50 Positive Percent Agreement 100% (27/27); 95% CI % 87.5-100% Negative Percent Agreement 100% (23/23); 95% CI 85.7-100% 95% CI: 95% score confidence interval 1 Blue-green/blue-grey colonies 2 No growth or colonies not blue-green/blue-grey 3 Includes strains of K. pneumoniae known to carry the following blaKPC variants: KPC-2: 11; KPC-3: 15 b. Clinical specificity: Refer to Section M(3)(a), above. 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: In the Prospective Clinical Study described in Section M(3)(a), the prevalence of 23 carbapenemase-producing E. coli and K. pneumoniae based on the reference enrichment culture method was 0.0% (0/709) and 7.2% (51/709), respectively. In contrast, the prevalence of presumptive carbapenemase-producing isolates of E. coli and K. pneumoniae observed on CHROMID CARBA agar was 0.3% (2/709) and 8.2% (58/709), respectively. 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:

idK181092_s10000_e12000

K181092.txt

conclusion

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

depicted in Table 7. A summary of the isolates tested is shown in Table 10. Each contrived specimen was spiked with a unique bacterial strain at a concentration equivalent to 1-10X the analytical LoD of the CHROMID CARBA agar (Section M(1)(d)). Testing was performed in a blinded fashion at four different sites. A summary of the results obtained on CHROMID CARBA agar in comparison to the expected organism identity and Carbapenemase Status is provided in Tables 11 (a) & (b). 20 Table 10. Isolates included in the Contrived Specimen Study Species Number of Isolates Tested Carbapenemase Status Positive Negative Citrobacter freundii 1 1 0 Enterobacter cloacae 4 4 0 Escherichia coli 38 20 1 18 Klebsiella oxytoca 1 1 0 Klebsiella ozaenae 1 1 0 Klebsiella pneumoniae 160 88 2 72 Kluyvera ascorbata 1 1 0 Morganella morganii 1 1 0 Proteus mirabilis 2 2 0 Raoultella ornithinolytica 1 1 0 Total 210 120 3 90 1 blaKPC: 11 (KPC-2: 9, KPC-3: 2); blaNDM: 4; blaOXA-48: 2; blaVIM: 2; blaIMP: 1 2 blaKPC: 77 (45 KPC-3, 30 KPC-2, 2 other variants); blaVIM: 4; blaNDM: 3; blaIMP: 2; blaOXA-48: 2 3 Overall, 110/120 isolates (92%) were positive for blaKPC, including 12/12 isolates (100%) of species other than E. coli and K. pneumoniae 21 Tables 11(a) & (b). Contrived Specimen Study: CHROMID CARBA agar Colony Color vs Expected Organism Identity and Carbapenemase Status Table 11(a): Carbapenemase-producing E. coli Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 16 2 3 18 Negative 2 4 4 188 192 Total 20 190 210 Positive Percent Agreement 80.0% (16/20); 58.4-91.9% Negative Percent Agreement 98.9% (188/190); 95% CI 96.2-99.7% 95% CI: 95% score confidence interval 1 Pink-burgundy colonies 2 No growth or colonies not pink-burgundy 3 2/2 isolates were carbapenem non-susceptible E. coli (resistant to meropenem and ertapenem and an intermediate MIC for imipenem); both isolates were positive for Extended Spectrum b-Lactamase (ESBL) 4 False negative results were obtained with 4 strains of carbapenem non-susceptible E. coli that harbored blaOXA-48 (2), blaNDM (1) and blaVIM (1) and which were spiked at target levels ranging from 1X to 10X LoD; 2/4 strains had an intermediate MIC to at least one carbapenem including 1 strain that was also susceptible to ertapenem Table 11(b): Carbapenemase-producing K. pneumoniae Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 84 11 3, 4 95 Negative 2 3 5 112 6 115 Total 87 123 210 Positive Percent Agreement 96.6% (84/87); 95% CI % 90.3-98.8% Negative Percent Agreement 91.1% (112/123); 95% CI 84.7-94.9% 95% CI: 95% score confidence interval 1 Blue-green/blue-grey colonies 2 No growth or colonies not blue-green/blue-grey 3 5/11 false positive results were obtained with carbapenem non-susceptible K. pneumoniae, all of which were positive for ESBL (3) or ESBL and AmpC (2) 4 6/11 false positive results were due to Carbapenemase Status-positive species of Enterobacteriaceae other than K. pneumoniae that harbored blaKPC: E. cloacae (4), K. oxytoca (1) and K. ozaenae (1) 5 3/3 false negative results were obtained with Carbapenemase Status positive isolates at the LoD target level; each strain carried a different carbapenemase resistance marker (blaIMP (1), blaKPC (1) or blaOXA-48 (1)); 2/3 strains had a susceptible or intermediate MIC to at least one of the three carbapenems tested (ertapenem, imipenem or meropenem) 6 18/112 samples contained carbapenem non-susceptible strains of K. pneumoniae of which 17 were phenotypically carbapenemase negative; 11/18 were positive for ESBL and 6/18 were positive for AmpC Challenge Study To supplement the results of the Prospective Clinical Study and Contrived Specimen Study, additional testing was performed using well characterized Carbapenemase Status-positive and -negative isolates of E. coli and K. pneumoniae that were suspended in saline at 3 x 103 CFU/mL (equivalent to 2X LoD [Section M(1)(d)]). Included in the study were strains with known blaKPC variants (KPC-2 [12], KPC-3 22 [18] and KPC-4 [1]). Samples were blinded and tested at one study site. A summary of the results is provided in Tables 12 (a) & (b). Table 12 (a) & (b). Challenge Study: CHROMID CARBA agar Colony Color vs Expected Organism Identity and Carbapenemase Status Table 12(a): Carbapenemase-producing E. coli Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 12 3 0 12 Negative 2 0 38 38 Total 12 38 50 Positive Percent Agreement 100% (12/12); 75.8-100% Negative Percent Agreement 100% (38/38); 95% CI 90.8-100% 95% CI: 95% score confidence interval 1 Pink-burgundy colonies 2 No growth or colonies not pink-burgundy 3 Includes strains of E. coli known to carry the following blaKPC variants: KPC-2: 1; KPC-3: 3; KPC-4: 1 Table 12(b): Carbapenemase-producing K. pneumoniae Organism Identity & Carbapenemase Status Positive Negative Total CHROMID CARBA agar Positive 1 27 3 0 27 Negative 2 0 23 23 Total 27 23 50 Positive Percent Agreement 100% (27/27); 95% CI % 87.5-100% Negative Percent Agreement 100% (23/23); 95% CI 85.7-100% 95% CI: 95% score confidence interval 1 Blue-green/blue-grey colonies 2 No growth or colonies not blue-green/blue-grey 3 Includes strains of K. pneumoniae known to carry the following blaKPC variants: KPC-2: 11; KPC-3: 15 b. Clinical specificity: Refer to Section M(3)(a), above. 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: In the Prospective Clinical Study described in Section M(3)(a), the prevalence of 23 carbapenemase-producing E. coli and K. pneumoniae based on the reference enrichment culture method was 0.0% (0/709) and 7.2% (51/709), respectively. In contrast, the prevalence of presumptive carbapenemase-producing isolates of E. coli and K. pneumoniae observed on CHROMID CARBA agar was 0.3% (2/709) and 8.2% (58/709), respectively. 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:

idK161258_s0_e2000

K161258.txt

purpose for submission

New Device

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Purpose for submission:

idK161258_s0_e2000

K161258.txt

measurand

Anti-Neutrophil Cytoplasmic Antibodies (ANCA)

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Measurand:

idK161258_s0_e2000

K161258.txt

type of test

Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Type of test:

idK161258_s0_e2000

K161258.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Classification:

idK161258_s0_e2000

K161258.txt

product code

MOB, Aneutrophil cytoplasmic antibodies (ANCA)

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Product code:

idK161258_s0_e2000

K161258.txt

panel

Immunology (82)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Panel:

idK161258_s0_e2000

K161258.txt

predicate device name

NOVA Lite ANCA

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Predicate device name:

idK161258_s0_e2000

K161258.txt

applicant

Inova Diagnostics, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Applicant:

idK161258_s0_e2000

K161258.txt

regulation section

21 CFR §866.5660, Multiple autoantibodies immunological test system

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K161258 B. Purpose for Submission: New Device C. Measurand: Anti-Neutrophil Cytoplasmic Antibodies (ANCA) D. Type of Test: Qualitative and/or semi-quantitative indirect immunofluorescence (IIF) assays E. Applicant: Inova Diagnostics, Inc. F. Proprietary and Established Names: NOVA Lite DAPI ANCA (Ethanol) Kit NOVA Lite DAPI ANCA (Formalin) Kit G. Regulatory Information: 1. Regulation section: 21 CFR §866.5660, Multiple autoantibodies immunological test system 2. Classification: Class II 3. Product code: MOB, Aneutrophil cytoplasmic antibodies (ANCA) 4. Panel: Immunology (82) H. Intended Use: 1. Intended use(s): 2 NOVA Lite DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings, aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite DAPI ANCA (Formalin) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological, radiological, histological, and clinical findings aids in the diagnosis of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): 1. For prescription use only. 2. The device is for use by a trained operator in a clinical laboratory setting. 3. All software-aided results must be confirmed by the trained operator. Special instrument requirements: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope. I. Device Description: NOVA Lite DAPI ANCA (Ethanol) and DAPI ANCA (Formalin) Kits are indirect immunofluorescence assays for the qualitative detection and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies of IgG isotypes in human serum. Kit components include: · ANCA (Formalin Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant, or ANCA (Ethanol Fixed Human Neutrophils) Slides; 12 wells/slide, with desiccant · FITC IgG Conjugate with DAPI, containing 0.09% sodium azide, ready to use · Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen, containing 0.09% sodium azide; pre-diluted, ready to use. · Negative Control: IFA System Negative Control, diluted human serum with no ANCA present, containing 0.09% sodium azide; pre-diluted, ready to use. · PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II. · Mounting Medium, containing 0.09% sodium azide · Coverslips Not provided in kit: NOVA View Automated Fluorescence Microscope (cleared in K153150) or Olympus CX31 with a FRAEN LED (Blue 480nm) or equivalent microscope J. Substantial Equivalence Information: 1. Predicate device name: 3 NOVA Lite ANCA 2. Predicate 510(k) number: K961340 3. Comparison with predicate: Similarities Item Candidate Predicate Intended use NOVA Lite® DAPI ANCA (Ethanol) Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG isotypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. NOVA Lite® DAPI ANCA (Formalin) Kit is an indirect immunofluorescence An indirect immunofluorescent test system utilizing ethanol-fixed human neutrophil substrate slides for detection of anti- neutrophil cytoplasmic antibodies (ANCA) in human serum. Detection of ANCA when used in conjunction with other laboratory and clinical findings aids in the assessment of various systemic vasculitides, such as Wegener's granulomatosis, microscopic polyarteritis and crescentic glomerulonephritis. 4 Similarities Item Candidate Predicate assay for the qualitative detection and semi-quantitative determination of anti- neutrophil cytoplasmic antibodies (ANCA) of IgG istoypes in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of ANCA, in conjunction with other serological tests and clinical findings aids in the assessment of ANCA associated vasculitides. A trained operator must confirm results when generated with the NOVA View device. ANCA Formalin test is not intended to be used by itself, but in conjunction with ANCA Ethanol test. Reported Result Qualitative and semiquantiative Semi-quantitative Analyte Anti-neutrophil cytoplasmic antibodies of IgG isotype Same Methodology Indirect immunofluorescence assay Same Manual Interpretation Manual fluorescence microscopy Same Antigen Human neutrophil granulocytes, on 12- well slides, ethanol fixed or formalin fixed. Same Sample Matrix Serum Same Slides 12-well coated with antigen Same Sample dilution 1:20 Same Conjugate FITC conjugated anti-human IgG (Fc specific) Same Controls Positive Controls: cANCA and pANCA; human serum with antibodies to proteinase 3 (PR3) and myeloperoxidase (MPO) antigen. Negative Control: IFA System Negative Control, diluted human serum with no ANCA present. Same Storage 2–8ºC Same Shelf life 18 months Same 5 Differences Item Device Predicate Automated Interpretation NOVA View® Automated Fluorescence Microscope Manual only Additional dye in Conjugate 4',6-diamidino-2-phenylindole (DAPI) None K. Standard/Guidance Document Referenced: 1. Evaluation of Precision Performance of Quantitative Measurement Methods (CLSI EP05-A3) 2. Interference Testing in Clinical Chemistry (CLSI EP07-A2) 3. Method Comparison and Bias Estimation Using Patient Samples (CLSI EP09-A3) L. Test Principle: Samples are diluted 1:20 in PBS and incubated with the antigen substrate (human neutrophil granulocytes fixed on glass microscope slides). After incubation, unbound antibodies are washed off. The substrate is then incubated with anti-human IgG-FITC conjugate. The conjugate contains the DNA-binding blue fluorescent dye, 4',6-diamidino-2-phenylindole (DAPI) that is required for NOVA View® Automated Fluorescence Microscope use. The blue dye is not visible by traditional fluorescence microscope at the wavelength where FITC fluorescence is viewed. Unbound reagent is washed off, and the slides are coverslipped. Stained slides are read by manual fluorescence microscopy, or scanned with the NOVA View Automated Fluorescence Microscope. The resulting digital images are reviewed and interpreted from the computer monitor. ANCA positive samples exhibit an apple green fluorescence corresponding to areas of the cell where autoantibody has bound. Manual interpretation of NOVA Lite DAPI ANCA (Ethanol) Kit: The two major patterns on ethanol-fixed substrate are cytoplasmic or C-ANCA, and perinuclear or P-ANCA. C-ANCA: C-ANCA samples present as coarse speckled cytoplasmic fluorescence, often with accentuated staining between the nuclear lobes. This pattern is characteristic for antibodies reacting with PR3. P-ANCA: P-ANCA samples present as perinuclear staining with or without nuclear extension. This pattern is usually characteristic for Regulation section:

idK161258_s14000_e16000

K161258.txt

proposed labeling

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

8 (80.0–94.0) 92.4 (87.2–95.6) NOVA View® Automated 83.8 (74.2–90.3) 96.8 (92.8–98.6) 30 Fluorescence Microscope Site 2: NOVA Lite DAPI ANCA (Ethanol) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 75 (64.5–83.2) 57.0 (49.2–64.4) Digital Read 71.3 (60.5–80.0) 65.6 (57.9–72.6) NOVA View® Automated Fluorescence Microscope 70.0 (59.2–78.9) 69.5 (61.8–76.2) NOVA Lite DAPI ANCA (Formalin) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 80.0 (70.0–87.3) 90.5 (84.9–94.2) Digital Read 81.3 (71.3–88.3) 94.3 (89.5–97.0) NOVA View® Automated Fluorescence Microscope 76.3 (65.9–84.2) 94.3 (89.5–97.0) Site 3: NOVA Lite DAPI ANCA (Ethanol) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 72.5 (61.9–81.1) 63.9 (56.2–71.0) Digital Read 72.5 (61.9–81.1) 65.8 (58.1–72.8) NOVA View® Automated 70.0 (59.2–78.9) 68.4 (60.7–75.1) 31 Fluorescence Microscope NOVA Lite DAPI ANCA (Formalin) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 77.5 (67.2–85.3) 93.0 (88.0–96.1) Digital Read 76.3 (65.9–84.2) 94.3 (89.5–97.0) NOVA View® Automated Fluorescence Microscope 75.0 (64.5–83.2) 96.8 (92.8–98.6) b. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: See analytical cut-off. 5. Expected values/Reference range: Expected values were analyzed on 89 samples from apparently healthy subjects: 29 females, 54 males, 6 with unknown gender, with mean age of 45.7 years (range of 18-68). With NOVA Lite DAPI ANCA (Ethanol) Kit, there were four positive results with NOVA View® Automated Fluorescence Microscopesoftware interpretation, eight with manual interpretation, and four with digital interpretation. There were no positive results with NOVA Lite DAPI ANCA (Formalin) Kit testing, by any interpretation method. 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:

idK161258_s14000_e16000

K161258.txt

conclusion

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

88.8 (80.0–94.0) 92.4 (87.2–95.6) NOVA View® Automated 83.8 (74.2–90.3) 96.8 (92.8–98.6) 30 Fluorescence Microscope Site 2: NOVA Lite DAPI ANCA (Ethanol) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 75 (64.5–83.2) 57.0 (49.2–64.4) Digital Read 71.3 (60.5–80.0) 65.6 (57.9–72.6) NOVA View® Automated Fluorescence Microscope 70.0 (59.2–78.9) 69.5 (61.8–76.2) NOVA Lite DAPI ANCA (Formalin) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 80.0 (70.0–87.3) 90.5 (84.9–94.2) Digital Read 81.3 (71.3–88.3) 94.3 (89.5–97.0) NOVA View® Automated Fluorescence Microscope 76.3 (65.9–84.2) 94.3 (89.5–97.0) Site 3: NOVA Lite DAPI ANCA (Ethanol) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 72.5 (61.9–81.1) 63.9 (56.2–71.0) Digital Read 72.5 (61.9–81.1) 65.8 (58.1–72.8) NOVA View® Automated 70.0 (59.2–78.9) 68.4 (60.7–75.1) 31 Fluorescence Microscope NOVA Lite DAPI ANCA (Formalin) Kit N=238 Sensitivity % (95% CI) Specificity % (95% CI) Manual Read 77.5 (67.2–85.3) 93.0 (88.0–96.1) Digital Read 76.3 (65.9–84.2) 94.3 (89.5–97.0) NOVA View® Automated Fluorescence Microscope 75.0 (64.5–83.2) 96.8 (92.8–98.6) b. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: See analytical cut-off. 5. Expected values/Reference range: Expected values were analyzed on 89 samples from apparently healthy subjects: 29 females, 54 males, 6 with unknown gender, with mean age of 45.7 years (range of 18-68). With NOVA Lite DAPI ANCA (Ethanol) Kit, there were four positive results with NOVA View® Automated Fluorescence Microscopesoftware interpretation, eight with manual interpretation, and four with digital interpretation. There were no positive results with NOVA Lite DAPI ANCA (Formalin) Kit testing, by any interpretation method. 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: