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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Aspartate Aminotransferase assay, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance
Correlation Coefficient	High correlation to predicate (Boehringer Mannheim AST assay on Hitachi 717)	0.999
Slope	Close to 1.0 (indicating proportional agreement)	0.893
Y-intercept	Close to 0 U/L (indicating minimal constant bias)	-1.815 U/L
Total %CV (Within-run, Between-run, Between-day) - Level 1	Undefined, but expected to be low for precision	1.6%
Total %CV (Within-run, Between-run, Between-day) - Level 2	Undefined, but expected to be low for precision	1.2%
Linearity	Undefined, but expected to cover a relevant clinical range	Up to 4,202 U/L
Limit of Quantitation (Sensitivity)	Undefined, but expected to be clinically relevant	1.5 U/L

Note: The acceptance criteria are implied by the substantial equivalence claim. The filing states the new assay "yields similar Performance Characteristics" to the predicate, and the provided results are presented as demonstrating this equivalence. Specific numerical thresholds for acceptance are not explicitly defined in the document.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Comparative performance studies were conducted," but does not specify the number of samples or patients used in these studies.
Data Provenance: Not explicitly stated. It is an in vitro diagnostic assay, so data would likely be from human serum or plasma samples. The country of origin and whether the data was retrospective or prospective are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in vitro diagnostic assay for a quantitative measurement, not a device relying on expert interpretation (e.g., imaging devices). The "ground truth" for comparative performance is the measurements obtained from the predicate device.

4. Adjudication method for the test set

Not applicable. As noted above, this is for a quantitative assay validation, not a study requiring human adjudication of results. The comparison is directly between the new device's readings and the predicate device's readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay. MRMC studies are typically for devices that assist human interpretation, such as AI in medical imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance characteristics reported are for the device operating in a standalone capacity (i.e., algorithm only without human-in-the-loop performance). The device directly quantifies aspartate aminotransferase in serum/plasma.

7. The type of ground truth used

The "ground truth" for the performance study establishing substantial equivalence was the measurements obtained from the legally marketed predicate device: the Boehringer Mannheim AST assay on the Hitachi 717 Analyzer. This is a common approach for in vitro diagnostic devices seeking 510(k) clearance by demonstrating equivalence to an existing product.

8. The sample size for the training set

Not applicable. This document describes the validation of an in vitro diagnostic assay based on chemical reactions, not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. As specified in point 8, there is no "training set" in the context of this device's validation.

Summary

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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 (972) 518-6711 Fax (972) 753-3367

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:

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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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/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:

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

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

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)

Regulation Number and Section

§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(a)
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.(b)
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.