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

Device 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.

AI/ML Overview

The Abbott Laboratories' AST Activated (Aspartate Aminotransferase Activated) assay is an in vitro diagnostic device for the quantitative determination of aspartate aminotransferase in human serum or plasma. The provided document is a 510(k) summary for this device, comparing it to an existing predicate device to establish substantial equivalence.

Here's the breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device (Abbott Aspartate Aminotransferase Activated) were implicitly defined by its ability to demonstrate "similar Performance Characteristics" and "acceptable correlation" when compared to the legally marketed predicate device (Boehringer Mannheim® Aspartate Aminotransferase Activated assay on the Hitachi® 717 Analyzer). The intent was to show that the new device performs at least as well as the predicate.

Performance Characteristic	Acceptance Criteria (Implicit - based on predicate similarity)	Reported Device Performance (Abbott AST Activated)
Method Comparison	Acceptable correlation with predicate device	Correlation coefficient = 0.9983, slope = 0.838, Y-intercept = -0.764 U/L (vs. Boehringer Mannheim on Hitachi 717)
Precision (Total %CV)	Similar to predicate / Clinically acceptable	Level 1: 5.3%
		Level 2: 2.4%
Linearity	Clinically appropriate range	Up to 410 U/L
Limit of Quantitation (Sensitivity)	Clinically appropriate minimum detection	9 U/L
Assay Range	Minor difference from predicate acceptable	Acknowledged as a minor difference from predicate

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for the comparative performance studies. It states "Comparative performance studies were conducted..." but does not provide the number of samples.
Data Provenance: The document does not explicitly state the country of origin of the data. It is a retrospective comparison against a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not relevant or applicable for an in vitro diagnostic assay like this. The "ground truth" for chemical assays is established by the performance of a recognized reference method or a legally marketed predicate device, not by expert consensus in the same way it would be for image interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. The comparison is quantitative, based on chemical measurements rather than subjective interpretation requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are typically used for imaging-based diagnostic devices where human readers interpret images. This device is a quantitative chemical assay.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Performance Characteristics" section details the following standalone performance metrics for the Aspartate Aminotransferase Activated assay:

Precision studies: Within-run, between-run, and between-day studies were performed.
Linearity: Tested up to 410 U/L.
Limit of quantitation (sensitivity): Determined as 9 U/L.

7. Type of Ground Truth Used

For the comparative performance study, the "ground truth" was established by the results obtained from the legally marketed predicate device, the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

8. Sample Size for the Training Set

Not applicable. This device is a chemical assay, so there is no "training set" in the context of machine learning algorithms. The development of such an assay involves chemical and enzymatic optimization, not data-driven training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The assay development would involve established biochemical principles and experimental validation using reference materials and established methods.

Summary

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K981221

APR 23 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 (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 2, 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.

198 1221 The assigned 510(k) number is:

Test Description:

Section II Page 1

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Substantial Equivalence:

The Aspartate Aminotransferase Activated assay is substantially equivalent to the Boehringer Mannheim® Aspartate Aminotransferase Activated assay on the Hitachi® 717 Analyzer (K861792) for the serum application.

These 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 in serum or plasma.
Both assays yield similar clinical results. .

Differences:

. There is a minor difference between the assay range.

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 ALCYON™ Analyzer. The Aspartate Aminotransferase assay method comparison yielded acceptable correlation with the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application. For the serum application, the correlation coefficient = 0.9983, slope = 0.838, and Y-intercept = - 0.764 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 111 is 5.3% and Level 2/Panel 112 is 2.4%. The Aspartate Aminotransferase Activated assay is linear up to 410 U/L. The limit of quantititation (sensitivity) of the

Section II Page 2

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Aspartate Aminotransferase Activated assay is 9 U/L. These data demonstrate that the performance of the Aspartate Aminotransferase Activated assay is substantially equivalent to the performance of the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer for the serum application.

Conclusion:

The Aspartate Aminotransferase Activated assay is substantially equivalent to the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Aspartate Aminotransferase Activated 510(k) April 1, 1998 ASTAE2.lwp

Section II Page 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its head, body, and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 23 1998

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

K981221 Re : Aspartate Aminotransferase Activated Requlatory 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 exclosure) 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. 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 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 addrass "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

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:

(Division Sign-Off)
Division of Clinical Laboratory Devices
410(k) Number K981221

(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)

00000000

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.