ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30

K974001 · Diagnostic Chemicals , Ltd. · CIT · Nov 13, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974001
• Device Name: ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CIT · Clinical Chemistry
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.

Device Story

In vitro diagnostic assay for quantitative determination of aspartate aminotransferase (AST) in serum samples. Used in clinical laboratory settings by trained personnel. Measures AST levels to assist in clinical assessment of myocardial infarction, hepatic disease, and hepatic necrosis. Results provide diagnostic information to healthcare providers for patient management and monitoring of organ function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical assay for AST quantification in serum. Reagent-based chemistry system. Class I device.

Indications for Use

Indicated for the quantitative determination of aspartate aminotransferase (AST) in serum to aid in the diagnosis of myocardial infarction, hepatic disease, and other internal organ diseases.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 13 1997

Ms. Karen Callbeck, R.T., B.Sc. Regulatory Affairs Coordinator Diagnostic Division Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE, CANADA

Re : K974001 Aspartate Aminotransferase-SL Assay, Trade Name: Catalogue Number 319-10, 319-30 Requlatory Class: I Product Code: CIT Dated: October 15, 1997 Received: October 21, 1997

Dear Ms. Callbeck:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 may 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 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 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 at [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Aspartate Aminotransferase-SL Assay

## Indications For Use:

For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.

Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of diseases of some internal organs.

- 1. Burtis, C.A., Ashwood, E. R. (Ed.), Tietz Textbook of Clinical Chemistry, W.B. Saunders Co., Toronto pp790-791 (1994).
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K94001

Prescription Use_ (Per 21 CFR 801.109)

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)