CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)

K980528 · Chiron Diagnostics Corp. · MMI · Mar 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980528
• Device Name: CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
• Applicant: Chiron Diagnostics Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Mar 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the quantitative determination of cardiac troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS: 180® Automated Chemiluminescence Systems.

Device Story

The Chiron Diagnostics ACS:180 Troponin I Assay is an in vitro diagnostic test used on the ACS:180 Automated Chemiluminescence System. It measures cardiac troponin I levels in serum or heparinized plasma samples. The assay utilizes chemiluminescence technology to quantify troponin I, providing results that assist clinicians in diagnosing acute myocardial infarction. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a quantitative concentration value, which healthcare providers use to evaluate cardiac injury and inform clinical decision-making regarding patient management and treatment for myocardial infarction.

Technological Characteristics

In vitro diagnostic assay utilizing chemiluminescence technology for the quantitative measurement of cardiac troponin I. Designed for use on the Chiron Diagnostics ACS:180 Automated Chemiluminescence System. Analyzes serum or heparinized plasma samples.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I in serum or heparinized plasma to aid in the diagnosis of acute myocardial infarction in patients suspected of having a 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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William J. Pignato Director of Requlatory Affairs Chiron Diagnostics 63 North Street Medfield, Massachusetts 02052-1688

MAR - 3 1998

Re : K980528 Chiron Diagnostics ACS:180® Troponin I Assay Regulatory Class: II Product Code: MMI Dated: February 10, 1998 Received: February 11, 1998

Dear Mr. Pignato:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set torth 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 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/dsmamain.html".

Sincerely yours,
Steven Aitman

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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Company Confidential

Page of of ___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

14980528

Device Name: Chiron Diagnostics ACS:180 Troponin I Assay

Indications for Use:

For the quantitative determination of cardiac troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS: 180® Automated Chemiluminescence Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division: of Clinical Laboratory Devices
510(k) Number: k980528