Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Device Description

Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Laboratories Activated AST assay, structured to address your specific points:

Since this document describes a diagnostic assay and not an AI/ML device, many of the requested points related to AI/ML specific studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable. The study design described is a comparative performance study against a predicate device, which is standard for in vitro diagnostic (IVD) assays for 510(k) clearance.

Acceptance Criteria and Study Summary for Abbott Laboratories Activated AST Assay

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly defined by the demonstration of comparable performance to the predicate device, specifically in terms of correlation (regression analysis) and precision.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (New Device vs. Predicate)
Method Comparison (Correlation Coefficient)	High correlation (e.g., >0.97, common for IVD) with predicate device.	- Abbott AEROSET: 0.999 (slope 1.06, Y-intercept 3.79 U/L) - ARCHITECT c8000: 0.999 (slope 1.01, Y-intercept -4.15 U/L) - ARCHITECT c16000: 0.999 (slope 1.03, Y-intercept -3.75 U/L)
Precision (Total %CV)	Acceptable within-laboratory precision for different AST levels (typically varies by concentration).	ARCHITECT c8000: - Level 1 (43 U/L): 4.5% (20 Day) - Level 2 (192 U/L): 1.0% (20 Day) - Level 3 (23 U/L): 2.4% (5 Day) - Level 4 (3,437 U/L): 0.7% (5 Day) AEROSET System: - Level 1 (46 U/L): 2.3% (5 Day) - Level 2 (205 U/L): 0.7% (5 Day) ARCHITECT c16000 System: - Level 1 (45 U/L): 1.8% (5 Day) - Level 2 (197 U/L): 0.5% (5 Day)
Linearity	Demonstrate accuracy across a clinically relevant range.	Linear up to 1,985 U/L.
Limit of Quantitation (LoQ)	Define the lowest concentration that can be accurately measured.	5 U/L (with Flex Rate linearity up to 5,364 U/L).

The study demonstrates that the Abbott Laboratories Activated AST assay on various Abbott platforms (AEROSET, ARCHITECT c8000, ARCHITECT c16000) achieves a very high correlation (0.999) with the predicate device (Abbott AST Activated, K981221) on the AEROSET System. The reported precision (total %CV) values are varied but generally low, indicating good reproducibility. The linearity and limit of quantitation also support the device's performance across its intended measuring range.

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

Sample Size for Test Set: The document does not explicitly state the number of samples used for the method comparison (correlation) or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted," providing the results without specific sample counts for each.
Data Provenance: The document does not specify the country of origin of the data. Given the "Abbott Laboratories" submitter in Irving, TX, USA, it is highly probable the studies were conducted in the USA. The studies are prospective in nature, as they involve running samples on the new device and comparing them to a predicate device, which implies collecting or generating data for the specific purpose of the 510(k) submission.

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

This is not applicable as this is an in vitro diagnostic assay, not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this assay is the measurement obtained from the legally marketed predicate device, which itself would have undergone rigorous validation.

4. Adjudication Method for the Test Set

Not applicable for an in vitro diagnostic assay. Performance is assessed by direct comparison of numerical results to the predicate device and established analytical performance metrics (e.g., correlation, precision).

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, not an AI/ML device for aiding human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For an IVD, the "standalone" performance is essentially what is evaluated. The device itself (reagents + instrument system) performs the measurement. The results of the comparative performance studies and precision studies represent the standalone performance of the assay. There isn't an "algorithm only" in the sense of AI/ML, but rather the chemical reaction and photometric measurement by the instrument.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Abbott AST Activated assay, K981221 on the Abbott AEROSET System). The goal is to show the new device yields "similar results" and "similar Performance Characteristics" to this predicate.

8. The Sample Size for the Training Set

Not applicable. This is an IVD assay, not an AI/ML device that requires a training set in that context. The "training" for such a system would involve method development and optimization, but not in the sense of machine learning.

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

Not applicable, as there is no "training set" in the context of an AI/ML device. For an IVD, the initial method development and optimization would rely on established analytical chemistry principles and potentially reference methods, but this is distinct from establishing ground truth for machine learning.

Summary

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K07/525

MAR 1 9 2008

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist, MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479

Date of Preparation of this Summary:	May 31, 2007Updated March 17, 2008
Device Trade or Proprietary Name:	Activated AspartateAminotransferase
Device Common/Usual Name orClassification Name:	Activated AST
Classification Number/Class:	Class II / 862.1100
Product Code:	CIT

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 862.1100.

K071525 The assigned 510(k) number is:

Test Description:

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Substantial Equivalence:

The Abbott Laboratories Activated AST assay on the Abbott AEROSET and ARCHITECT cSystems is substantially equivalent to the Abbott AST Activated (K981221) assay on the AERO$ET System. Both assays yield similar Performance Characteristics.

Similarities:

Both assays use NADH (with P-5'-P) methodology .
. Both assays can be used for the quantitation of AST
. Both assays yield similar results
Both assays use serum and plasma .

Differences:

Abbott Laboratories Activated Aminotransferase is a liquid reagent. Aspartate Aminotransferase Activated is a lyophilized reagent requiring reconstitution prior to use.

Intended Use:

The Abbott Laboratories Activated 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.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET and ARCHITECT cSystems. The Abbott Laboratories Activated AST assay, LN 08L91, method comparison yielded acceptable correlation between the following reagent/instrument comparisons:

Next Generation Activated AST 510(k) March 17, 2008

Section II Page 2

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1. Abbott Laboratories Activated AST assay on the AEROSET vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
1. Abbott Laboratories Activated AST on the ARCHITECT c8000 vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).
1. Abbott Laboratories Activated AST on the ARCHITECT c16000 System vs. Abbott AST Activated (K981221) on the Abbott AEROSET System (Predicate Device).

Results consisted of:

1. The Abbott Laboratories Activated A.ST assay on the Abbott AEROSET System showed a correlation coefficient of 0.999, slope of 1.06, and Y-intercept of 3.79 U/I . when compared to the Predicate Device.
1. The Abbott Laboratories Activated AST on the ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 1.01, and Y-intercept of -4.15 U/L when compared to the Predicate Device.
1. The Abbott Laboratories Activated AST on the ARCHITECT c16000 System showed a correlation coefficient of 0.999, slope of 1.03, and Y-intercept of -3.75 U/L when compared to the Predicate Device.

The Abbott Laboratories Activated AST assay run on the Abbott AEROSET and ARCHITECT cSystems method comparison results yielded acceptable correlation to the Abbott AST Activated assay on the Abbott AEROSET System.

Precision studies were conducted using the Abbott Laboratories Activated AST assay. On the ARCHITECT c8000 System, the 20 Day total %CV for Level 1 (43 U/L) is 4.5%, and Level 2 (192 U/L) is 1.0% and the 5 Day total %CV for Level 3 (23 U/L) is 2.4% and Level 4 (3,437 U/L) is 0.7%. On the AEROSET System, the 5 Day total %CV for Level 1 (46 U/L) is 2.3% and Level 2 (205 U/L) is 0.7%. On the ARCHITECT c16000 System, the 5 Day total %CV for Level 1 (45 U/L) is 1.8% and Level 2 (197 U/I.) is 0.5%.

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The Abbott Laboratories Activated AST assay is linear up to 1,985 U/L. The limit of quantitation of the Abbott Laboratories Activated AST assay is 5 U/L, with Flex Rate linearity up to 5,364 U/L.

These data demonstrate that the performance of the Abbott Laboratories Activated AST assay is substantially equivalent to the performance of the Abbott AST Activated assay, I.N 08D37 (K981221) on the AEROSET and ARCHITECT cSystems.

Conclusion :

The Abbott Laboratories Activated AST assay on the AEROSET System and ARCHITECT cSystems is substantially equivalent to the Abbott AST Activated assay, LN 08D37 (K981221) on the AEROSET System and ARCHITECT cSystems as demonstrated by results obtained in the studies.

Next Generation Activated AST 510(k) March 17, 2008

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Abbot Laboratories c/o Ms. Linda Morris Senior Regulatory Specialist 1920 Hurd Drive Irving, TX 75038

MAR 1 9 2008

Re: K071525

Trade/Device Name: Next Generation Activated Asparate Aminotransferase Assay Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system. Regulatory Class: Class II Product Code: CIT Dated: March 10, 2008 Received: March 11, 2008

Dear Ms. Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 011525

Device Name: _ Abbott Laboratories Activated Aspartate Aminotransferase

Indications For Use:

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

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Office of In Vitro Diagnostic Device
Evaluation and Safety

4071525

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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.