TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)

K993353 · Bayer Corp. · MMI · Dec 6, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993353
• Device Name: TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

This in vitro diagnostic method intended to quantitatively measure the concentration of cardiac Troponin 1 (Tn1) in human serum and plasma (lithium heparin) using the Bayer Immuno 1 system. When used in conjunction with other clinical data, such as presenting symptoms and diagnostic procedures, measurements of cardiac Tnl aids in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revalcularization procedures. This diagnostic method is not intended for use on any other system.

Device Story

Bayer Immuno 1 System Troponin I assay is an enzyme-labeled sandwich immunoassay; utilizes monoclonal and polyclonal antibodies. Input: human serum or plasma samples. Process: sample mixed with fluorescein-labeled monoclonal antibody, alkaline phosphatase (ALP)-labeled goat antibody, and magnetizable particles coated with anti-fluorescein antibody; incubation at 37°C forms a sandwich complex captured on magnetic particles; particles washed; para-nitrophenyl phosphate substrate added; ALP reacts to form para-nitrophenoxide. Output: absorbance measured at 405 nm and 450 nm; concentration calculated via linear point-to-point dose-response curve. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing AMI and performing risk stratification for patients with non-ST segment elevation acute coronary syndromes, facilitating decisions regarding urgent revascularization.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is based on technical performance and intended use comparison to the previously cleared predicate device.

Technological Characteristics

Enzyme-labeled sandwich immunoassay; solid phase consists of magnetizable particles coated with anti-fluorescein antibody. Detection via absorbance at 405 nm and 450 nm. Assay range 0 to 200 ng/mL. Uses liquid calibrators. System-specific for Bayer Immuno 1.

Indications for Use

Indicated for quantitative measurement of cardiac Troponin I in human serum and plasma to aid in the diagnosis of acute myocardial infarction (AMI) and for risk stratification of patients with non-ST segment elevation acute coronary syndromes regarding mortality, myocardial infarction, or ischemic events requiring urgent revascularization.

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

• Bayer Immuno 1™ System Troponin I Method (K973616)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC - 6 1999

K993353

## 510(k) Summary of Safety and Effectiveness Information

、武

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

| Sponsor: | Gabriel Muraca, Manager RA<br>Bayer Corporation<br>Business Group Diagnostics<br>511 Benedict Avenue<br>Tarrytown, N.Y. 10591-5097<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Bayer Immuno 1™ System Troponin I Method |
| Classification Name: | Immunoassay Method |
| Predicate Device: | Bayer Immuno 1™ System Troponin I Method |

## Device Description:

The proposed Bayer Immuno 1™ Troponin I assay is an enzyme label sandwich assay using a monoclonal and polyclonal antibody. A Troponin I specific monoclonal antibody is labeled with fluorescein and a Troponin I specific goat affinity purified antibody is labeled with alkaline phosphatase (ALP). The solid phase consists of a suspension of magnetizable particles coated with antibody to fluorescein (mIMP reagent). Sample or calibrator, R1 reagent containing fluoresceinantibody conjugate, R2 reagent containing ALP-antibody conjugate and mIMP reagent are mixed and incubated at 37° C. In the presence of Troponin I a (fluorescein-conjugate: Troponin I:ALPconjugate) complex is formed and captured by the anti-fluorescein antibodies on the magnetic particles. The particles are washed and para-nitrophenyl phosphate solution is added. The ALP in the antibody conjugate reacts with the substrate to form para-nitrophenoxide and phosphate. Increasing absorbance due to the formation of para-nitrophenoxide is monitored at 405 nm and 450 nm. The dose response curve is directly proportional to the concentration of Troponin I in the sample. A linear point to point fit is used to construct the dose response curve. The Bayer Immuno 1 Troponin I assay has a range of 0 to 200 ng/mL and liguid calibrators are provided with values of 0,5,10,20,60, and 200 ng/mL Troponin I.

The Bayer Immuno 1 Troponin I Assay was previously cleared under Document Control No. K973616. The proposed Bayer Immuno 1 Troponin I Assay is substantially equivalent in technical performance and intended use to the FDA cleared device. Changes are limited to modifications in the indications for use. The additional indication for use is:

...in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction or increased probability of ischemic events requiring urgent revascularization procedures.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 6 1998

Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: K993353

Trade Name: Troponin I Assay for the Bayer Immuno 1™ System Regulatory Class: II Product Code: MMI Dated: September 30, 1999 Received: October 5, 1999

Dear Mr. Muraca:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 QS 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 Register. 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 regulations.

{2}------------------------------------------------

## Page 2

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 regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{3}------------------------------------------------

510(k) Number (if known):

Device Name: Troponin I

Indications For Use:

This in vitro diagnostic method intended to quantitatively measure the concentration of cardiac Troponin 1 (Tn1) in human serum and plasma (lithium heparin) using the Bayer Immuno 1 system. When used in conjunction with other clinical data, such as presenting symptoms and diagnostic procedures, measurements of cardiac Tnl aids in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revalcularization procedures.

This diagnostic method is not intended for use on any other system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

Optional Formal 1-2-96

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K993353 |
|---------------|---------|
|---------------|---------|