AST

K981843 · Abbott Laboratories · CIT · Jun 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981843
• Device Name: AST
• Applicant: Abbott Laboratories
• Product Code: CIT · Clinical Chemistry
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

The Aspartate Aminotransferase Activated assay is used for the quantitation of aspartate aminotransferase in human serum or plasma.

Device Story

In vitro diagnostic assay for quantitative determination of aspartate aminotransferase (AST) in human serum or plasma. Principle: AST catalyzes transamination of aspartate and alpha-ketoglutarate to produce oxaloacetate and glutamate; oxaloacetate is reduced to malate by malate dehydrogenase (MDH) with concomitant oxidation of NADH to NAD. Rate of NADH oxidation measured at 340 nm is proportional to AST activity. Reagent includes lactate dehydrogenase (LD) to consume endogenous pyruvate. Used in clinical laboratory settings; operated by laboratory technicians. Output is a quantitative AST activity value (U/L) used by physicians to diagnose and monitor liver and heart disease.

Clinical Evidence

Bench testing only. Method comparison study on AEROSET System vs. Abbott SPECTRUM predicate yielded correlation coefficient of 0.9932, slope of 0.856, and Y-intercept of -8.749 U/L. Precision studies (within-run, between-run, between-day) showed total %CV of 5.4% (Level 1) and 1.4% (Level 2). Assay is linear up to 993.2 U/L with a limit of quantitation of 5.6 U/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Reagents include malate dehydrogenase (MDH) and lactate dehydrogenase (LD). Measurement via spectrophotometry at 340 nm. Designed for use on the AEROSET System. Quantitative, linear up to 993.2 U/L.

Indications for Use

Indicated for the quantitative determination of aspartate aminotransferase (SGOT) in human serum or plasma to aid in the diagnosis and treatment of liver and heart disease.

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.

Predicate Devices

• Abbott SPECTRUM™ Aspartate Aminotransferase Activated (K894180)

Submission Summary (Full Text)

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K981843

## JUN 2 9 1998

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | May 22, 1998 |
|--------------------------------------|---------------|
| Device Trade or Proprietary Name: | AST Activated |

Device Common/Usual Name or Classification Name: Aspartate Aminotransferase Activated

Classification Number/Class: 75CIT/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

#### Test Description:

Aspartate Aminotransferase Activated is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase Activated assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transamination of aspartate and ox-ketoglutarate to produce oxaloacetate and glutamate. Oxaloacetate is subsequently reduced to malate by malate dehydrogenase (MDH) with the concomitant oxidation of NADH to NAD. The rate of NADH oxidation is measured by 340 nm and is proportional to the AST activity of the sample. In addition, this reagent contains lactate dehydrogenase (LD) which consumes endogenous pyruvate during the first four minutes of the incubation period.

Section II Page 1

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#### Substantial Equivalence:

The Aspartate Aminotransferase Activated assay is substantially equivalent to the Abbott SPECTRUM™ Aspartate Aminotransferase Activated (K894180) assay for the serum application.

These assavs vield similar Performance Characteristics.

Similarities to Abbott:

- Both assays are in vitro clinical chemistry methods. .
- . Both assays can be used for the quantitative determination of aspartate aminotransferase in serum or plasma.
- Both assays vield similar clinical results. .

Differences to Abbott:

- . There is a minor difference between the assay ranges.
#### Intended Use:

The Aspartate Aminotransferase Activated assay is used for the quantitation of aspartate aminotransferase in human serum or plasma.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Aspartate Aminotransferase assay method comparison yielded acceptable correlation with the Abbott SPECTRUM Aspartate Aminotransferase Activated assay for the serum application. The correlation coefficient = 0.9932, slope = 0.856, and Y-intercept = -8.749 U/L. Precision studies were conducted using the Aspartate Aminotransferase Activated assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 5.4% and Level 2/Panel 102 is 1.4%. The Aspartate Aminotransferase Activated assay is linear up to 993.2 U/L. The limit of quantititation (sensitivity) of the Aspartate Aminotransferase Activated assay is 5.6 U/L. These data demonstrate

Section II Page 2

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that the performance of the Aspartate Aminotransferase Activated assay is substantially equivalent to the performance of the Abbott SPECTRUM Aspartate Aminotransferase Activated assay for the serum application.

#### Conclusion:

The Aspartate Aminotransferase Activated assay is substantially equivalent to the Abbott SPECTRUM Aspartate Aminotransferase Activated assay as demonstrated by results obtained in the studies.

Aspartate Aminotransferase Activated 510(k) May 21, 1998 ASTAf lwp

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jun 29 1998

Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981843 AST Requlatory Class: II Product Code: CIT Dated: May 22, 1998 May 26, 1998 Received:

Dear Mr. Littlefield:

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. 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 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 Bitman

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 Activated

Indications For Use:

The Aspartate Aminotransferase Activated assay is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

(Division Sizn-Sif) Division of Clincal Laboratory 510(k) Number.

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Concurence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801 109)

(Optional Format 1-2-96)