AST

K983131 · Abbott Laboratories · CIT · Sep 28, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983131
• Device Name: AST
• Applicant: Abbott Laboratories
• Product Code: CIT · Clinical Chemistry
• Decision Date: Sep 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic assay for quantitative determination of aspartate aminotransferase (AST) in human serum or plasma. Operates on AEROSET System; utilizes enzymatic reaction where NADH is oxidized to NAD; decrease in absorbance at 340 nm measured to quantify AST levels. Used in clinical laboratory settings by trained personnel. Results provided to clinicians to assist in diagnosis and management of liver and heart disease.

Clinical Evidence

Bench testing only. Method comparison study against predicate (Hitachi 717) showed correlation coefficient of 0.999, slope 0.893, and Y-intercept -1.815 U/L. Precision studies reported total %CV of 1.6% (Level 1) and 1.2% (Level 2). Assay linear up to 4,202 U/L; limit of quantitation is 1.5 U/L.

Technological Characteristics

In vitro clinical chemistry assay. Principle: enzymatic oxidation of NADH to NAD. Measured via spectrophotometry at 340 nm. Designed for use on the AEROSET System. Quantitative measurement range up to 4,202 U/L.

Indications for Use

Indicated for the quantitative determination of aspartate aminotransferase 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

• Boehringer Mannheim AST assay (K861792)

Submission Summary (Full Text)

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2983131

SEP 28 1998

# 510(k) Summary

### Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | September 4, 1998 |
|--------------------------------------------------|----------------------------|
| Device Trade or Proprietary Name: | Aspartate Aminotransferase |
| Device Common/Usual Name or Classification Name: | AST |
| Classification Number/Class: | 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: 183131

## 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 in which NADH is oxidized to NAD. The resulting decrease in absorbance at 340 nm is indicative of the presence of aspartate aminotransferase.

### Substantial Equivalence:

The Aspartate Aminotransferase assay is substantially equivalent to the following device:

Boehringer Mannheim® AST assay (K861792) on the Hitachi® 717 Analyzer . Both assays yield similar Performance Characteristics.

Aspartate Aminotransferase 510(k) September 4, 1998 Ast

Section II Page 1

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## Similarities:

- Both assays are in vitro clinical chemistry methods. .
- . Both assays can be used for the quantitative determination of AST.
- . Both assays vield similar clinical results.
- Both assays are based on the oxidation of NADH to NAD. .

#### Differences:

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

The Aspartate Aminotransferase 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 vielded acceptable correlation with the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.893 and Y-intercept = -1.815 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 101 is 1.6% and Level 2/Panel 102 is 1.2%. The Aspartate Aminotransferase assay is linear up to 4,202 U/L. The limit of quantitation (sensitivity) for the Aspartate Aminotransferase assay is 1.5 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase assay is substantially equivalent to the performance of the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer.

Aspartate Aminotransferase 510(k) September 4, 1998 Ast

Section II Page 2

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 28 1998

Linda Morris .Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038

Re : K983131 Aspartate Aminotransferase Regulatory Class: II Product Code: CIT Dated: September 4, 1998 Received: September 8, 1998

Dear Ms. Morris:

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 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 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 [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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510(k) Number (if known): \$983|3| ___

Device Name:

Indications For Use:

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

| (Division Sign-Off) | |
|-----------------------------------------|-----------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | k 9831 31 |

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

(Optional Format 1-2-96)