SPECTRAL'S 2 IN 1 (TNI-MYO)

K020950 · Spectral Diagnostics, Inc. · MMI · May 24, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020950
• Device Name: SPECTRAL'S 2 IN 1 (TNI-MYO)
• Applicant: Spectral Diagnostics, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in human whole blood, plasma or serum as an aid in the diagnosis of myocardial infarction in point-of-care, and hospital settings.

Device Story

Spectral's 2 in 1 (TnI-Myo) test is an in vitro diagnostic device for the qualitative detection of cardiac troponin I and myoglobin. It utilizes human whole blood, plasma, or serum samples. The device is designed for professional use in hospital and point-of-care settings to assist clinicians in the diagnosis of myocardial infarction. By providing rapid qualitative results for these cardiac markers, the test supports timely clinical decision-making for patients presenting with symptoms of cardiac distress.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on regulatory review of the 510(k) notification.

Technological Characteristics

In vitro diagnostic test for qualitative determination of cardiac troponin I and myoglobin. Form factor is a test device for use with human whole blood, plasma, or serum. Professional use only.

Indications for Use

Indicated for the qualitative determination of cardiac troponin I (cTnI) and myoglobin in human whole blood, plasma, or serum to aid in the diagnosis of myocardial infarction. Intended for professional use in 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Nisar A. Shaikh Director of Quality Systems Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario M9C 1C2 CANADA

MAY 2 4 2002

k020950 Re:

Trade/Device Name: Spectral's 2 in 1 (TnI-Myo) test Regulation Numbers: 21 CFR 862.1215; 21 CFR 866.5680 Regulation Names: Creatine phosphokinase/creatine kinase or isoenzymes test system; Myoglobin immunological test system Regulatory Class: Class II; Class II Product Code: MMI; DEA Dated: March 22, 2002

Dear Dr. Shaikh:

Received: March 25, 2002

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 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 notification. The I Dri imating of succion 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 (2) CFR Part 801 and 1 II you desire specific acrice for your astic devices), please contact the Office of Compliance at additionally 807.10 for in viue allestions on the promotion and advertising of your device, [phone]. Truditional ) , IST 453-4639. 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 Information on your respond and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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 2 in 1 (TnI-Myo) Test 510(k) Notification

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

Device Name : Spectral's 2 in 1 (TnI-Myo) test

Indications for Use: For the qualitative determination of cardiac troponin I
ndications for the top the belocked blood, plasma or serum as an aid in the Indications for Use: For the quality coocorative coocorative as an aid in the (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.

Jean Cooper

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Division of Clin.
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510(k) Number.

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

Professional Use: X

OD

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

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Prescription Use: X (Per 21 CFR 801.109) OR

SDI Ref #: R-003/2002-510K