ABBOTT AXSYM TROPONIN-I ADV

K060875 · Abbott Laboratories · MMI · Jun 14, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060875
• Device Name: ABBOTT AXSYM TROPONIN-I ADV
• Applicant: Abbott Laboratories
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

Device Story

Abbott AxSYM Troponin-I ADV is an in vitro diagnostic assay for quantitative measurement of cardiac Troponin-I (cTnI) in human serum or plasma. Device uses Microparticle Enzyme Immunoassay (MEIA) technology on the AxSYM System. Reagents include anti-troponin-I coated microparticles, biotin-conjugated anti-troponin-I, and alkaline phosphatase-conjugated anti-biotin. System measures enzyme activity to determine cTnI concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing myocardial infarction and stratifying risk for patients with acute coronary syndromes. Output provides quantitative cTnI values, aiding clinical decision-making regarding patient prognosis and management.

Clinical Evidence

Clinical performance evaluated via method comparison study against predicate. Study included 546 specimens. Results showed correlation coefficient (r) of 0.97 and 0.95 for dynamic range. No other clinical data provided.

Technological Characteristics

Microparticle Enzyme Immunoassay (MEIA). Reagents: mouse monoclonal anti-troponin-I coated microparticles, biotin-conjugated anti-troponin-I, alkaline phosphatase-conjugated anti-biotin. Instrumentation: Abbott AxSYM Analyzer. Sample types: serum or heparinized plasma. Storage: 2 to 8 degrees C.

Indications for Use

Indicated for quantitative determination of cardiac troponin-I in human serum or plasma to assist in diagnosis of myocardial infarction and risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) regarding mortality, myocardial infarction, or ischemic events.

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

• Beckman Coulter Access AccuTnI assay

Submission Summary (Full Text)

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K060875

### 510(k) Summary

JUN 1 4 2006

## Abbott AxSYM® Troponin-I ADV

# 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 ADV constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the AxSYM Troponin-I ADV assay and the Beckman™ Coulter Access® AccuTnI assay The intended use of the AxSYM Troponin-I ADV assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to assist in the diagnosis of myocardial infarction, and in the risk stratification of patients with acute coronary syndromes, (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. The intended use of the Beckman Coulter Access AccuTnI assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin-I determination aids in the risk stratification of patients with unstable angina or 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.

| Regression Method | n | r | Slope | Intercept |
|---------------------------------------|-----|------|-------|-----------|
| Passing-Bablok<br>(All Specimens) | 546 | 0.97 | 1.47 | -0.05 |
| Passing-Bablok<br>(ADV Dynamic Range) | 531 | 0.95 | 1.47 | -0.05 |

n = number of specimens

r = correlation coefficient

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In conclusion, these data demonstrate that the AxSYM Troponin-I ADV assay is as safe and effective as, and is substantially equivalent to, the Beckman Coulter Access AccuTnI assay.

Prepared and submitted 29 March 2006 by:

Margaret Derchinik 3/29/06

Abbott Laboratories Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept. 9VA, Bldg AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: [phone] Fax: E-Mail: [e-mail]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9VA AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500

JUN 1 4 2006

Re: k060875

> Trade/Device Name: Abbott AxSYM® Troponin-I ADV Reagent Regulation Number: 21 CFR§862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 29, 2006 Received: March 30, 2006

Dear Ms. Prochniak:

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Gutierrez, Ph.D. 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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# Indications for Use

510(k) Number (if known):_KOLeO875

Device Name: Abbott AxSYM® Troponin-I ADV Reagent

Indications For Use:

The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060875