ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30

K974003 · Diagnostic Chemicals , Ltd. · CKA · Dec 5, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974003
• Device Name: ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CKA · Clinical Chemistry
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Intended Use

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

Device Story

Alanine Aminotransferase-SL Assay is an in vitro diagnostic reagent used for the quantitative measurement of ALT levels in serum samples. Used in clinical laboratory settings by trained personnel. The assay provides numerical results reflecting ALT concentration, which clinicians use to assess liver function, detect hepatic disease, or monitor conditions like myocardial infarction. Elevated ALT levels serve as a biomarker for tissue damage, particularly in the liver, allowing for early detection of hepatic necrosis before clinical symptoms like jaundice manifest. The assay supports clinical decision-making regarding patient diagnosis and management of internal organ diseases.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic assay evaluated via bench-top performance characteristics typical for clinical chemistry reagents.

Technological Characteristics

In vitro diagnostic reagent for quantitative enzymatic determination of ALT in serum. Operates via standard clinical chemistry spectrophotometric analysis. Form factor is a liquid reagent system. No specific software, connectivity, or complex instrumentation described.

Indications for Use

Indicated for the quantitative determination of alanine aminotransferase (ALT) in serum to aid in the diagnosis of myocardial infarction or hepatic disease, including hepatic necrosis prior to the onset of jaundice, and diseases of internal organs.

Regulatory Classification

Identification

An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 5 1997

Karen Callbeck, R.T.B.Sc. . Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charolettetown, PE Canada C1E, 1B0

Re : K974003 Alanine Aminotransferase-SL Assay Requlatory Class: T Product Code: CKA Dated: October 17, 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 The general controls provisions of the Act 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. ಡಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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K974003/A'

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Alanine Aminotransferase-SL Assay

197400

## Indications For Use:

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

Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent 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, p 790-791 (1994).
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Ser-Off)
Division of Clinical Laboratory Laboratory Devices Devices
510(k) Number k974003

**Prescription Use**
(Per 21 CFR 801.109)

OR

**Over-The-Counter Use** ***_***

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