SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

K030057 · Spectral Diagnostics, Inc. · MMI · Mar 19, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030057
• Device Name: SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
• Applicant: Spectral Diagnostics, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Mar 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.

Device Story

Spectral Cardiac STATus™ CK-MB/Myoglobin/Troponin I 3-in-1 test is an in vitro diagnostic immunoassay. It utilizes human whole blood, plasma, or serum samples to qualitatively detect three cardiac markers: CK-MB, myoglobin, and cardiac troponin I. The device is intended for use in emergency rooms, critical care units, point-of-care settings, and hospitals by healthcare professionals. It provides rapid results to aid in the clinical diagnosis of acute myocardial infarction. The output is a qualitative result used by clinicians to inform immediate patient management and diagnostic decision-making.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's intended use and technological characteristics as an immunoassay for cardiac markers.

Technological Characteristics

Immunoassay method for the qualitative determination of CK-MB, myoglobin, and cardiac troponin I. Utilizes chromatographic separation. Classified under 21 CFR 862.1215 (Product Codes: MMI, JHT, DDR).

Indications for Use

Indicated for qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma, or serum to aid in the diagnosis of acute myocardial infarction in patients in emergency, critical care, point-of-care, and hospital settings.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 1 9 2003

Dr. Nisar A. Shaikh Director of Quality Systems Spectral Diagnostics Inc. 135 The West Mall Toronto, Ontario Canada M9C 1C2

> k030057 Trade/Device Name: Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test Regulation Number: 21 CFR § 862.1215 Regulation Name: Immunoassay Method, Troponin Subunit, Chromatographic Separation, CPK Isoenzymes Regulatory Class: II Product Code: MMI, JHT, DDR Dated: January 3, 2003 Received: January 7, 2003

Dear Dr. Shaikh:

Re:

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. Iisting 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). 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

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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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Spectral Diagnostics Inc. Spectral Cardiac STATus™ CK-MB/Myoglobin/Troponin I 3-in-1 510(k) Notification

## KU3005 510(k) Number (if Known) : Not Known at this time

Device Name: Spectral Cardiac STATus™ CK-MB/Myoglobin/Troponin I 3-in-1 test

Indications for Use: For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.

Ham
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030057

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

OR

Professional Use:

Prescription Use: (Per 21 CFR 801.109) Over the counter use: (Optional Format 1-2-96)