SPECTRAL'S TROPONIN I

K014105 · Spectral Diagnostics, Inc. · MMI · Feb 1, 2002 · Clinical Chemistry

Device Facts

• Record ID: K014105
• Device Name: SPECTRAL'S TROPONIN I
• Applicant: Spectral Diagnostics, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

Device Story

Spectral's Troponin I is an in vitro diagnostic test for quantitative measurement of cardiac troponin I. Input samples include human whole blood, serum, or plasma. Used in emergency rooms, critical care, point-of-care, and hospital settings to aid in diagnosing myocardial infarction. Provides rapid results to healthcare providers to facilitate clinical decision-making regarding cardiac events.

Technological Characteristics

In vitro diagnostic test system for quantitative determination of cardiac troponin I. Analyzes human whole blood, serum, and plasma samples. Classified under 21 CFR 862.1215 (Product Code MMI).

Indications for Use

Indicated for rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma to aid in the diagnosis of myocardial infarction in patients in emergency room, 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 01 2002

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

Re: k014105

Trade/Device Name: Spectral's Troponin I Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: December 11, 2001 Received: December 13, 2001

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, 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 I notification. The FDA finding of substantial equivalence of your device to a legally marketed nouthoution. The I Dr 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 11 you dolly 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, (301) 59 r tact 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 1101) 443-6597 or at its internet address "http://www.fda.gov/odrh/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 Troponin I Test 510(k) Notification

## Kol4105

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

Device Name : Spectral's Troponin I

Indications for Use:

The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the The Speculars Troponial Problem Interdiac troponin I in human whole blood, serum, and Tapid quantanve decemiination of can ocardial infarction in emergency room, critical care, point of care and hospital settings.

Geon Cooper

(Division Sign-Off)
Division of Clinical Laborato:
510(k) Number K01405

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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)