ASPARTATE AMINOTRANSFERASE (AST)

K981225 · Abbott Laboratories · CIT · Apr 23, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981225
• Device Name: ASPARTATE AMINOTRANSFERASE (AST)
• Applicant: Abbott Laboratories
• Product Code: CIT · Clinical Chemistry
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

The Aspartate Aminotransferase (AST) 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 in sample catalyzes transfer of amino group from aspartate to alpha-ketoglutarate to form oxalacetate and glutamate; oxalacetate reduced to malate by malate dehydrogenase (MD) with concurrent oxidation of NADH to NAD. Rate of decrease in absorbance at 340 nm is proportional to AST activity. Lactate dehydrogenase (LD) added to prevent interference from endogenous alpha-keto acids. Used in clinical laboratory settings on automated chemistry analyzers (e.g., ALCYON Analyzer). Results used by clinicians to aid in diagnosis and treatment of liver and heart disease.

Clinical Evidence

Bench testing only. Method comparison study on ALCYON Analyzer vs. Roche Cobas Mira Plus showed correlation coefficient 0.9967, slope 0.935, Y-intercept 2.794 U/L. Precision studies (within-run, between-run, between-day) reported total %CV of 9.2% (Level 1) and 2.3% (Level 2). Linearity established up to 430 U/L; limit of quantitation is 9 U/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Reagents include lactate dehydrogenase (LD), malate dehydrogenase (MD), and NADH. Photometric measurement of absorbance decrease at 340 nm. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of aspartate aminotransferase in human serum or plasma for the diagnosis and treatment of certain types 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

• Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay (K924244)

Submission Summary (Full Text)

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K981225

APR 2 3 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: | April 02, 1998 |
|--------------------------------------------------|----------------------------|
| Device Trade or Proprietary Name: | AST |
| Device Common/Usual Name or Classification Name: | Aspartate Aminotransferase |
| 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 is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase assay is a clinical chemistry assay. Lactate dehydrogenase (LD) is added to prevent interference from endogenous a-keto acids. Aspartate aminotransferase in the sample catalyzes the transfer of the amino group from aspartate to x-ketogluterate to form oxalacetate and glutamate. The oxalacetate formed is reduced to malate in the presence of malate dehydrogenase (MD) with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). The resulting rate of decrease in absorbance at 340 nm is proportional to the AST activity in the sample.

Aspartate Aminotransferase 510(k) April 1, 1998 ASTunfE2.lwp

Section II Page 1

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#### Substantial Equivalence:

The Aspartate Aminotransferase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Aspartate Aminotransferase assay (K924244).

Both assays vield similar Performance Characteristics.

Similarities:

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

Differences:

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

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

#### Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Aspartate Aminotransferase assay method comparison vielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay. The correlation coefficient = 0.9967, slope = 0.935, and Y-intercept = 2.794 U/L. Precision studies were conducted using the Aspartate Aminotransferase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/ Panel 111 is 9.2% and Level 2/Panel 112 is 2.3%. The Aspartate Aminotransferase assay is linear up to 430 U/L. The limit of quantitation (sensitivity) for the Aspartate Aminotransferase assay is 9 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase assay is substantially equivalent to the performance of the

Section II Page 2

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Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay.

### Conclusion:

The Aspartate Aminotransferase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay as demonstrated by results obtained in the studies.

Aspartate Aminotransferase 510(k) April 1, 1998 ASTunfE2.lwp

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 23 1998

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

Re : K981225 Aspartate Aminotransferase Regulatory Class: II Product Code: CIT Dated: April 2, 1998 Received: April 3, 1998

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 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. ਰ 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 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 [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: _________________________________________________________________________________________________________________________________________________________________

ﻌﻨﺎ ﺍ

Indications For Use:

The Aspartate Aminotransferase (AST) assay is used for the quantitation of aspartate aminotransferase in human serum or plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number. k981225

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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