← Product Code [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT) · K991663

# AST/SGOT (K991663)

_A.P. Total Care, Inc. · CIT · Jun 30, 1999 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K991663

## Device Facts

- **Applicant:** A.P. Total Care, Inc.
- **Product Code:** [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT.md)
- **Decision Date:** Jun 30, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1100
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Intended Use

The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.

## Device Story

AST (SGOT) reagents are in vitro diagnostic chemical reagents used for the quantitative determination of Aspartate Aminotransferase levels in human serum or plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The reagents facilitate a chemical reaction that allows for the measurement of AST activity, which is used by clinicians to assess liver function and diagnose potential hepatic or cardiac conditions. The output is a quantitative measurement of enzyme activity, which assists healthcare providers in clinical decision-making regarding patient health status.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

In vitro diagnostic chemical reagents for AST (SGOT) determination. Reagent kit includes product numbers 117-01 and 117-02. Operates via standard biochemical assay principles for enzyme activity measurement in serum or plasma samples.

## Regulatory 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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Image /page/0/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three stripes representing its wings and tail feathers. The eagle is facing to the right.

JUN 30 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

A.P. Total Care c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, Connecticut

Re: K991663 Trade Name: AST (SGOT) Regulatory Class: II Product Code: CIT Dated: May 5, 1999 Received: May 14, 1999

Dear Mr. Leon:

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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 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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## Page 2

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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/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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l l Page __of

| 510(k) Number (if known): | K991663 |
|---------------------------|---------|
|---------------------------|---------|

AST (SGOT)

| Device Name: |  |
|--------------|--|
|--------------|--|

Indications For Use:

The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro The ADT (SOOT) - reagents, productive determination of AST (SGOT) in serum, or plasma.

longg
(Division Sign-Off)

Division of Clinical Laboratory Devices × 991663 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

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