TROPONIN (TROP) METHOD

K973650 · Dade Chemistry Systems, Inc. · MMI · Oct 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973650
• Device Name: TROPONIN (TROP) METHOD
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Device Story

TROP method is a one-step enzyme immunoassay for the Dimension® RxL clinical chemistry system. Input: human serum or plasma sample. Process: sample incubated with chromium dioxide particles coated with monoclonal antibody (2F6.6) and ALP-labeled monoclonal antibody (2B1.9) to form a sandwich; magnetic separation removes unbound components; ALP initiates amplification cascade (dephosphorylating FADP to FAD, activating D-amino acid oxidase, producing H2O2); HRP converts DCHBS and 4-AAP to a colored product. Output: colorimetric measurement at 510nm, proportional to cardiac troponin-I concentration. Used in clinical laboratories by technicians. Results assist physicians in diagnosing myocardial infarction and stratifying mortality risk in acute coronary syndrome patients.

Clinical Evidence

Split sample comparison between Dimension® RxL TROP method and Stratus® Cardiac Troponin-I assay. Sample size: 111 clinical patient samples. Range: 0.00 to 47.87 ng/mL. Results: correlation coefficient 0.9918, slope 1.10, intercept -0.075 ng/mL.

Technological Characteristics

Sandwich format monoclonal antibody immunoassay. Solid support: chromium dioxide particles. Detection: colorimetric rate measurement at 510nm and 700nm. Sample volume: 60μL. System: Dimension® RxL clinical chemistry system with heterogeneous immunoassay module.

Indications for Use

Indicated for patients with suspected myocardial infarction or acute coronary syndromes to aid in diagnosis and risk stratification for mortality.

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

• Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay (K973650)

Submission Summary (Full Text)

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OCT 2 0 1997

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Chemistry Systems 20 Box 6101 1010. 00 3114

## Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Rebecca S. Ayash<br>Dade International Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Phone: [phone]<br>FAX: [phone] |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation:<br>Device Name: | 9/24/97<br>Cardiac Troponin-I (TROP) Method |
| Classification Name: | Immunoassay Method, Troponin Subunit |
| Predicate Device: | Stratus® Cardiac Troponin-I Fluorometric Enzyme<br>Immunoassay |

Device Description: The TROP method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrOz) coated with a monoclonal antibody specific for cardiac troponin-1 and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibody specific for cardiac troponin-I] to form a particle/cardiac troponin-I/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipvrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of cardiac troponin-I present in the patient sample.

Intended Use: The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively

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Intended Use: The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

| Item | Dimension® RxL TROP | Stratus® Cardiac Troponin-I |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Sandwich format<br>monoclonal antibody<br>immunoassay | Sandwich format<br>monoclonal antibody<br>immunoassay |
| Monoclonal Antibodies<br>• Tag<br>• Capture | • 2B1.9<br>• 2F6.6 | • 2B1.9<br>• 2F6.6 |
| Detection | Colorimetric rate<br>measurement at 510nm<br>and 700nm | Front surface fluorometry<br>measurement at 577nm<br>and 600nm |
| Solid Support | Chrome | Glass fiber paper |
| Specimen type | serum or plasma | serum or plasma |
| Sample Size | 60μL | 100μL |
| Intended Use | For the quantitative<br>determination of cardiac<br>troponin-I levels in serum<br>and plasma | For the quantitative<br>determination of cardiac<br>troponin-I levels in serum<br>and plasma |
| Indications for Use | To aid in diagnosis of<br>myocardial infarction and<br>to aid in the risk<br>stratification of patients<br>with acute coronary<br>syndromes with respect<br>to their relative risk of<br>mortality | To aid in diagnosis of<br>myocardial infarction and<br>to aid in the risk<br>stratification of patients<br>with acute coronary<br>syndromes with respect<br>to their relative risk of<br>mortality |

## Comparison to Predicate Device:

Comments on Substantial Equivalence: Split sample comparison between the TROP method on the Dimension® RxL clinical chemistry system and the Stratus® cardiac Troponin-I assay gave a correlation coefficient of 0.9918, slope of 1.10 and an intercept of -0.075 ng/mL when tested with 111 clinical patient samples ranging from 0.00 to 47.87 ng/mL.

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Conclusion: The TROP method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Stratus® Cardiac Troponin-I assay based on the split sample comparison summarized on the previous page.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.

OCT 20 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade International, Inc. Building 500, Mailbox 514 P.O. Box 6101 19714-6101 Newark, Delaware

K973650 Re : Cardiac Troponin-I (TROP) Method Regulatory Class: II Product Code: MMI Dated: September 24, 1997 September 25, 1997 Received:

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may . be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications Statement

Device Name: Cardiac Troponin-l (TROP) Method

Indications for Use: The TROP method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure cardiac troponin-1 in serum and plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 9/24/97

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Concurrence of CDRH, Office of Device Evaluation (ODE)

73650

510(k) Number

Division Sign Off

Division Sign-Off/ Office of Device Evaluation

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