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.

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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aspartate Aminotransferase (AST) assay, structured according to your request:

Acceptance Criteria and Device Performance

This submission describes a substantial equivalence claim for an in vitro diagnostic device, meaning the new device (Abbott Laboratories AST assay) is being compared to a legally marketed predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Aspartate Aminotransferase assay). Therefore, the "acceptance criteria" are implied by the performance of the predicate device, and the new device aims to demonstrate "similar performance characteristics."

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Implied Acceptance Criteria (Based on Predicate)	Reported Device Performance (Abbott AST Assay)
Correlation Coefficient (vs. predicate)	Expected to be high (e.g., >0.95 or similar to predicate's known performance)	0.9967
Slope (vs. predicate)	Expected to be close to 1	0.935
Y-intercept (vs. predicate)	Expected to be close to 0	2.794 U/L
Total %CV (Level 1/Panel 111)	Not explicitly stated, but expected to be acceptable for clinical use (similar to predicate)	9.2%
Total %CV (Level 2/Panel 112)	Not explicitly stated, but expected to be acceptable for clinical use (similar to predicate)	2.3%
Linearity Range	Expected to be clinically relevant (similar to predicate)	Up to 430 U/L
Limit of Quantitation (Sensitivity)	Expected to be clinically relevant (similar to predicate)	9 U/L

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

Sample Size: Not explicitly stated. The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using two levels of control material." However, the exact number of patient samples or replicates used for these studies is not provided.
Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data nor whether the study was retrospective or prospective. Given it's a 510(k) summary for an in vitro diagnostic device, the data are almost certainly clinical samples, but details are absent.

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

Not Applicable. For an in vitro diagnostic assay like this (quantifying an analyte in biological fluid), "ground truth" is typically established by analytical methods rather than expert consensus on interpretation. The comparator method (Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay) serves as the reference for comparison. The performance of the predicate device would have been established through its own validation studies.

4. Adjudication Method for the Test Set:

Not Applicable. Since this is an analytical performance study comparing two quantitative methods, adjudication by human experts is not relevant. The assessment relies on statistical correlation and precision measures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC study is typically performed for image-based diagnostic devices where multiple human readers interpret cases. This submission is for an in vitro diagnostic assay, where the output is a quantitative value, not subject to human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, effectively. This is a standalone performance study. The AST assay itself is an automated chemical reaction and measurement system. Its performance (correlation with predicate, precision, linearity, sensitivity) is reported based on the algorithm/method itself, without human intervention in the result generation or interpretation for the purpose of this performance study. The device quantifies AST, and the reading is directly from the instrument.

7. The Type of Ground Truth Used:

Comparability to a Reference Method. The "ground truth" for assessing the new device's accuracy is its comparison to the Roche Cobas Mira Plus Automated Chemistry System Aspartate Aminotransferase assay (the legally marketed predicate device). The assumption is that the predicate device provides accurate AST measurements.

8. The Sample Size for the Training Set:

Not applicable/Not explicitly mentioned. For a traditional chemical assay like this, there isn't a "training set" in the sense of machine learning algorithms. The assay development process involves optimization and calibration using various reagents and known standards, but this is distinct from "training data" for an AI model.

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

Not applicable/Not explicitly mentioned. As noted in point 8, the concept of a "training set" and establishing "ground truth" for it doesn't directly apply in the same way to this type of chemical assay as it would to a machine learning device. Assay parameters are typically established through chemical principles, calibration with known standards, and optimization experiments. The document describes the chemical reaction and how the measurement is made.

Summary

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

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 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized human profiles incorporated into the design.

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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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 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:

(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)

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.