VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

K063243 · bioMerieux, Inc. · MMI · Dec 14, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063243
• Device Name: VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
• Applicant: bioMerieux, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in diagnosis of myocardial infarction.

Device Story

VIDAS Troponin I Ultra is an automated, quantitative, two-site sandwich ELFA immunoassay for cardiac troponin I (cTnI) in human serum or plasma. The device utilizes a disposable Solid Phase Receptacle (SPR) coated with mouse monoclonal anti-cTnI antibodies. The assay is performed on VIDAS or miniVIDAS instruments, which control all steps: sample incubation with alkaline phosphatase-labeled conjugate, wash cycles, and substrate (4-Methyl-umbelliferyl phosphate) addition. The enzyme catalyzes substrate hydrolysis into a fluorescent product, measured at 450nm. Fluorescence intensity is directly proportional to cTnI concentration. Used in clinical laboratories, the test provides quantitative results to assist physicians in diagnosing myocardial infarction. The system requires prescription use and is intended for serial sampling to monitor cardiac markers over time.

Clinical Evidence

Clinical performance was evaluated at two sites (US and France) with patients presenting with chest pain and suspected myocardial infarction. Total sample size was 602 (US) and 396 (France). Sensitivity and specificity were calculated at 0-6 hours and 4-12 hours post-admission using a 0.11 ng/mL cutoff. US site sensitivity was 69.44% (0-6h) and 97.22% (4-12h); specificity was 96.24% (0-6h) and 96.21% (4-12h). French site sensitivity was 78.45% (0-6h) and 98.70% (4-12h); specificity was 90.55% (0-6h) and 92.11% (4-12h).

Technological Characteristics

Two-site sandwich ELFA immunoassay. Solid phase: SPR coated with mouse monoclonal anti-cTnI antibody. Conjugate: alkaline phosphatase-labeled mouse monoclonal anti-cTnI antibody. Substrate: 4-Methyl-umbelliferyl phosphate. Energy source: automated VIDAS/miniVIDAS instrument optical scanner (450nm). Connectivity: standalone instrument. Calibration: traceable to NIST SRM 2921. Reportable range: 0.01-30 ng/mL.

Indications for Use

Indicated for use as an aid in the diagnosis of myocardial infarction in patients presenting with chest pain or suspected myocardial infarction.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Dimension RxL® Cardiac Troponin I (CTNI) Assay

Submission Summary (Full Text)

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K063243

DEC 1 4 2007

# 510(k) SUMMARY

# VIDAS® Troponin | Ultra (TNIU) Assay

### A. Submitter Information

| Submitter's Name:<br>Address: | bioMérieux, Inc.<br>595 Anglum Road<br>Hazelwood, MO 63042 |
|-------------------------------|------------------------------------------------------------|
| Contact Person: | Nikita S. Mapp |
| Phone Number: | 314-731-7474 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 11, 2006 |

### B. Device Name

| Trade Name: | VIDAS® Troponin I Ultra (TNIU) Assay |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | Troponin I Enzyme Immunoassay |
| Classification Name: | 21 CFR 862.1215, Product Code MMI<br>Immunoassay method, Troponin Subunit |

## C. Predicate Device Name

| Trade Name: | Dimension RxL® Cardiac Troponin I (CTNI) Assay |
|-------------|------------------------------------------------|
|-------------|------------------------------------------------|

## D. Device Description

The VIDAS Troponin I Ultra (TNIU) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are in the sealed TNIU Reagent Strips.

The sample is transferred into the wells containing anti-cardiac troponin i antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR for a specified length of time. Troponin I present in the specimen will bind to the anticardiac troponin i immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.

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A fluorescent substrate, 4-methylumbellifery| phosphate, is introduced into the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The optical scanner in the instrument measures the intensity of fluorescence. When the VIDAS TNIU assay is completed, the results are analyzed automatically by the computer, a test value is generated, and a report is printed for each sample.

#### E. Intended Use

VIDAS Troponin I Ultra (TNIU) Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique.

| Similarities | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------|---------------------|
| Item | VIDAS® TNIU | Dimension RxL® CTNI |
| Assay Principle | One-step automated immunoassay based on<br>sandwich principle | Same |
| Intended Use | Quantitative determination of human cardiac<br>troponin I in human serum or plasma (lithium<br>heparinate) | Same |
| Indications for Use | An aid in the diagnosis of mycocardial infarction | Same |
| Sample Type | Human serum or plasma (lithium heparin) | Same |
| Antibody | Capture: mouse monoclonal antibody<br>Conjugate: mouse monoclonal antibody<br>labeled with alkaline phosphatase | Same |

## F. Technological Characteristics Summary

| Differences | | |
|------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------|
| Item | VIDAS® TNIU | Dimension RxL® CTNI |
| Solid Phase | Solid Phase Receptacle (SPR) | Chrome |
| Final Detection of<br>troponin-I antigen | Fluorescence (ELFA) of 4-methyl-<br>umbelliferyl measured at 450 nm | Colorimetric rate measurement at 510<br>nm |
| Measurement range | 0.01 to 30 µg/L | 0.04 to 40 µg/L |
| Analytical Detection Limit | 0.01 µg/L | 0.04 µg/L |
| Hook effect | No hook effect found up to<br>concentrations of 1000 µg/L | No hook effect found up to<br>concentrations of 1800 µg/L |
| Sample Volume | 200 µl | 50 µl |
| Assay Time | ~20 minutes | ~17 minutes |

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## G. Performance Data

#### Nonclinical Testing

| | Dimension® RxL CTNI | VIDAS® TNIU |
|-----------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Expected Values | 97.5% of 101 apparently<br>healthy patients had values<br>of 0.00 -0.05 µg/L | 99% of 747 patients with no<br>cardiac symptoms had<br>values of <0.01 µg/l |
| Cut-off | 0.6-1.5 ng/mL | 0.11 µg/l |
| Specificity<br>Cardiac Troponin T | 1000 µg/L: 0.34% | 1000 µg/L: 0.2% |
| Cardiac Troponin C | 1000 µg/L: 0.00% | 1000 µg/L: <0.001 |
| Skeletal Troponin I | 1000 µg/L: 0.04% | 1000 µg/L: <0.001 |
| Analytical Detection Limit | 0.04 µg/L | < 0.01 µg/l |
| Dilution - Recovery Test | 98.6-106.4% | 80-120% |
| Interference | No significant interference | No significant interference |
| Bilirubin | 20 mg/dL | 510 µM |
| Hemoglobin | 1000 mg/dL | 332 µM |
| Lipemia (triglycerides) | 3000 mg/dL | 30 mg/ml |
| Hook Effect | 1800 ng/mL | 1000 µg/l |

#### Clinical Testing

Five-hundred and thirty-four samples were tested with both the VIDAS® TNIU Assay (Y) and the Dimension RxL ® CTNI Assay (X). Data from the sample comparison study was evaluated with a Passing-Bablok method and correlation coefficient and produced the following results:

Y = 0.42 X

Confidence interval for the slope: 0.38-0.44 Correlation coefficient = 0.97

#### H. Conclusion

The VIDAS Troponin I Ultra (TNIU) Assay is substantially equivalent to the Dimension RxL® Cardiac Troponin I (CTNI) Assay.

The 510(k) summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 4 2007

bioMérieux, Inc. c/o Ms. Nikita S. Mapp Senior Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042

Re: k063243 Trade/Device Name: Vidas Troponin I Ultra (TNIU) Assay, Model 30 448 21 CFR 862.1215 Regulation Number: Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System. Regulatory Class: Class II Product Code: MMI Dated: September 14, 2007 Received: September 17, 2007

Dear Ms. Mapp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): K063243

Device Name: VIDAS Troponin I Ultra (TNIU)

Indication For Use: VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzymc-Linked Fluorescent Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in the diagnosis of myocardial infarction.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K063243