SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

K022409 · Spectral Diagnostics, Inc. · JHT · Sep 30, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022409
• Device Name: SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
• Applicant: Spectral Diagnostics, Inc.
• Product Code: JHT · Clinical Chemistry
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the qualitative determination of CK-MB 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's Cardiac Status™ CK-MB Rapid Test is an in vitro diagnostic device for qualitative detection of CK-MB in human whole blood, plasma, or serum. Used in emergency, critical care, and point-of-care settings by healthcare professionals to aid in acute myocardial infarction (AMI) diagnosis. Device provides rapid results to facilitate clinical decision-making regarding cardiac patient management. Benefits include timely identification of AMI, potentially improving patient outcomes through faster intervention.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test system for CK-MB isoenzymes. Qualitative immunoassay format. Intended for professional use in clinical settings.

Indications for Use

Indicated for qualitative determination of CK-MB in human whole blood, plasma, or serum to aid in diagnosis of acute myocardial infarction (AMI) in patients presenting in emergency, critical care, or point-of-care 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 3 0 2002

Nisar Shaikh, Ph.D. Director of Quality Systems Spectral Diagnostics, Inc. 135-2 The West Mall Toronto. Ontario Canada M9C 1C2

k022409 Re:

Trade/Device Name: Spectral's Cardiac Status™ CK-MB Rapid Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHT Dated: July 22, 2002 Received: July 24, 2002

Dear Dr. Shaikh:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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Spectral Diagnostics Inc. Spectral's Cardiac Status™ CK-MB Rapid Test 510(k) Notification

K022409

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

Device Name: Spectral's Cardiac Status™ CK-MB Rapid test

Indications for Use: For the qualitative determination of CK-MB 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.

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K022469

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

Professional Use:

Prescription Use:

(Per 21 CFR 801.109)

OR

Over the counter use: (Optional Format 1-2-96)