TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I

K973126 · Biosite Incorporated · JHX · Oct 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973126
• Device Name: TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
• Applicant: Biosite Incorporated
• Product Code: JHX · Clinical Chemistry
• Decision Date: Oct 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be as an aid in the diagnosis of myocardial infarction.

Device Story

Triage Cardiac Panel is an in vitro diagnostic device for quantitative measurement of CK-MB, Myoglobin, and Troponin-I in heparinized whole blood samples. Used as an aid in the diagnosis of myocardial infarction. Device operates via immunoassay technology to detect cardiac markers. Intended for use in clinical laboratory settings by healthcare professionals. Results assist clinicians in evaluating patients presenting with symptoms of myocardial infarction, facilitating timely clinical decision-making and patient management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic immunoassay for quantitative measurement of CK-MB, Myoglobin, and Troponin-I. Sample type: heparinized whole blood. Class II device (Product Codes: JHX, MMI, DDR).

Indications for Use

Indicated for the quantitative measurement of CK-MB, Myoglobin, and Troponin-I in heparinized whole blood as an aid in the diagnosis of 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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OCT - 6 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

John F. Bruni, Ph.D. Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, California 92121

Re : K973126 The Triage® Cardiac Panel Requlatory Class: II Product Code: JHX, MMI, DDR Dated: August 19, 1997 Received: August 20, 1997

Dear Dr. Bruni:

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, Druq, 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. ಕ್ಕೆ 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 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 regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device mav 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 leqally 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.qov/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 Radioloqical Health

Enclosure

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5 IO(k) Number if known) _

Device Name: Triage® Cardiac Panel, Triage® Troponin-I, Triage® CK-MB, Triage® Myoglobin, Triage® Conce Namel Magger - Trage® Troponing Triage - Stephine, Pringe - Myoglobin and CK-MB
Troponin and Myoglobin, Triage® Troponin-I and CK-MB and Triage® Myoglobin and CK-MB

indications for Use:

For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be as an aid in the diagnosis of myocardial infarction.

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Concurrence of CDRH, Office of Device Evaluation (ODE) -

(Division Sign-Off)
Division of Clinical Laborator Devices) 26
510(k) Number. 97

Prescription Use

Over-The Counter Use

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