ABBOTT AXSYM TROPONIN-I

K974103 · Abbott Laboratories · MMI · Nov 25, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974103
• Device Name: ABBOTT AXSYM TROPONIN-I
• Applicant: Abbott Laboratories
• Product Code: MMI · Clinical Chemistry
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Abbott AxSYM® Troponin-I is a Microparticle Enzyme Immunoassay (META) for the quantitative determination of cardiac troponin-I in human serum or plasma on the Abbott AxSYM System. Measurements obtained by this device are used to assist in the diagnosis of acute myocardial infarction (AMI).

Device Story

Abbott AxSYM Troponin-I is a Microparticle Enzyme Immunoassay (MEIA) used for quantitative measurement of cardiac troponin-I in human serum or plasma. The device utilizes antibodies specific to the cardiac isotype of troponin-I; fluorescent signal intensity is directly proportional to troponin-I concentration in the sample. Operated on the Abbott AxSYM System in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing acute myocardial infarction (AMI). The assay provides objective quantitative data to support clinical decision-making regarding cardiac events.

Clinical Evidence

Multi-center study of 246 patients (689 observations) using serial sampling. Clinical diagnosis based on WHO criteria for AMI. Using a 2.0 ng/mL cutoff, the assay demonstrated 93.9% clinical sensitivity and 93.4% clinical specificity for the 49 patients who ruled-in for AMI.

Technological Characteristics

Microparticle Enzyme Immunoassay (MEIA). Automated in vitro diagnostic system. Uses antibodies specific for cardiac troponin-I. Signal detection via fluorescence proportional to analyte concentration. Calibrated with Abbott Troponin-I Calibrators; accuracy/precision verified with Abbott Troponin-I Controls.

Indications for Use

Indicated for the quantitative determination of cardiac troponin-I in human serum or plasma to assist in the diagnosis of acute myocardial infarction (AMI) in patients.

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

• Dade® Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay

Submission Summary (Full Text)

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K974103

NOV 2 5 1997

## Section II

510(k) Summary

AxS YM Troponin-I 510(k)
October 1997
stui510kJwp .

Section II

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## 510(k) Summary Abbott AxSYM® Troponin-I

## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott AxSYM® Troponin-I constitutes data supporting a substantially equivalent determination.

AxSYM Troponin-I is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma. AxSYM Troponin-I is calibrated with Abbott Troponin-I Calibrators. Abbott Troponin-I Controls are assayed for the verification of the accuracy and precision of the AxSYM System.

Substantial equivalence has been demonstrated between the AxSYM Troponin-I assay and the Dade® Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay.

The intended use of the AxSYM Troponin-I assay is for the quantitative determination of cardiac troponin-I in serum or plasma. Troponin-I values are used to assist in the diagnosis of acute myocardial infarction (AMI).

The intended use of the Stratus Cardiac Troponin-I assay is for the quantitative determination of cardiac troponin-I levels in serum and plasma. Cardiac troponin-I determinations 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.

Both assays are automated, in vitro immunoassays that use antibodies specific for the cardiac isotype of troponin-I. The fluorescent signal measured by both assays is directly proportional to the concentration of cardiac troponin-I in the sample. A Passing-Bablok linear regression analysis between these two assays, using 158 specimens, yielded a Spearman correlation coefficient of 0.851, a slope of 3.42 ng/mL, and Y-axis intercept of -1.09 ng/mL.

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In a multi-center clinical study, a total of 246 patients, representing 689 observations, were followed with serial sampling to rule-in or rule-out for AMI. Clinical diagnosis was based upon the World Health Organization (WHO) criteria for AMI. There were 49 patients who ruled-in for AMI. Using 2.0 ng/mL as a diagnostic cutoff, the AxSYM Troponin-I assay demonstrated a clinical sensitivity of 93.9% and a clinical specificity of 93.4%.

In conclusion, these data demonstrate that the AxSYM Troponin-I assay is as safe and effective as, and is substantially equivalent to the Dade Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay.

Prepared and Submitted October 30, 1997 by: Laura Granitz Senior Regulatory Specialist ADD Regulatory Affairs 1-847-938-0092 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

AxSYM Troponin-I 510(k) October 1997 atmi510k.lwp

## Section II Page 2

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines extending from its head, resembling wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, with the eagle positioned in the center of the text.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 25 1997

Granitz Laura · Senior Regulatory Specialist Abbott Laboratories 200 Abbott Park Road 60064-3537 Abbott Park, Illinois

Re : K974103 Abbott AxSYM® Troponin-I Requlatory Class: II Product Code: MMI October 30, 1997 Dated: Received: October 31, 1997

Dear Ms. Granitz:

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 general 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 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 In addition, FDA may publish further announcements action. 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.

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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 deboing 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/dsmamain.html".

Sincerely yours,
Steven Sutman

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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510(k) Number (if known): K 974103

Abbott AxSYM® Troponin-I Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Abbott AxSYM® Troponin-I is a Microparticle Enzyme Immunoassay (META) for_ the quantitative determination of cardiac troponin-I in human serum or plasma on the Abbott AxSYM System. Measurements obtained by this device are used to assist in the diagnosis of acute myocardial infarction (AMI).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> |
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| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | ________________ |
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(Optional Format 1-2-96)

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | <div> <span style="text-decoration: overline;">k94103</span> </div> |