The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Device Description

Kinetic Method. The principle is based on the following reaction system: GOT (AST) L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H + → L-Malate + NAD + The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST). AST or GOT: Aspartate Aminotransferase. MDH: Malate Dehydrogenase. NADH: Nicotinamide-Adenine Dinucleotide (Reduced) NAD + : Nicotinamide-Adenine Dinucleotide. H + : Proton.

AI/ML Overview

The provided document describes the "Wiener lab. GOT (AST) UV AA Líquida" test system, a quantitative in vitro diagnostic device for determining aspartate aminotransferase (AST or GOT) in human serum and plasma. The device's performance is compared to a predicate device, "Wiener lab. GOT (AST) UV," to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing key performance characteristics. The "acceptance criteria" are implicitly set by matching or improving upon the performance of the predicate device.

Performance Characteristic	Predicate Device (GOT (AST) UV)	New Device (GOT (AST) UV AA Líquida)	Acceptance Criteria Met?
Intended Use	Quantitative determination of Aspartate Aminotransferase in human serum and plasma.	Same	Yes
Test Principle	Kinetic Method, based on NADH disappearance.	Same	Yes
Reagents	Buffer: L-aspartate - TRIS. Substrate: NADH – MDH – LDH - 2-oxoglutarate.	Same core components, but reconfigured for "AA Líquida" (liquid ready-to-use).	Yes (Functional equivalence despite formulation difference)
Preparation of Working Reagent	Dissolution of Reagent with stated volume of Buffer.	Reagents may be used separately or as Monoreagent, mixing 4 parts Buffer and 1 part Substrate.	Yes (Improved convenience without altering fundamental reaction)
Wavelength of Reading	334 - 340 - 366 nm	340 nm	Yes (Within acceptable range, possibly optimized)
Linearity	470 U/l	700 U/l	Yes (Improved linearity)
Expected Values	Male: up to 38 U/l (37°C) Female: up to 32 U/l (37°C)	Same (Implicitly, as no change is indicated for fundamental biological range)	Yes
Within-run precision (Normal Level Serum)	CV = 4.4%	CV = 2.41%	Yes (Improved precision)
Within-run precision (High Level Serum)	CV = 1.3%	CV = 1.22%	Yes (Comparable/slightly improved precision)
Run-to-run precision (Normal Level Serum)	CV = 4.9%	CV = 2.26%	Yes (Improved precision)
Run-to-run precision (High Level Serum)	CV = 1.6%	CV = 2.16%	Yes (Comparable precision, slight increase but still within acceptable limits for a clinical assay, though not explicitly stated as 'improved')

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

The document does not explicitly state the sample sizes used for the precision and linearity studies. It only provides the results (e.g., CV values and linearity range). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

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

This information is not applicable in this context. This device is a quantitative diagnostic assay, not an imaging or interpretive diagnostic tool that requires expert human interpretation to establish ground truth for testing. The "ground truth" for linearity and precision studies would be derived from the known concentrations or activities of reference materials, or statistical analysis of repeated measurements, not expert consensus on individual cases.

4. Adjudication Method for the Test Set:

This is not applicable for the type of device and studies presented. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or other data where consensus among experts is needed.

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:

This is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers.

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

This is not applicable in the sense of an "algorithm only" performance. The device is a chemical reagent system. Its performance (precision, linearity) is inherently "standalone" in the context of the assay itself, as it measures a biochemical parameter directly. There is no human interpretative "loop" in the direct performance of the assay.

7. The Type of Ground Truth Used:

For linearity, the ground truth would be based on known concentrations or activities of control materials or serially diluted samples.
For precision, the ground truth is established statistically by repeated measurements on stable control materials or patient samples to assess the reproducibility of the assay.

8. The Sample Size for the Training Set:

The document does not specify a training set in the context of machine learning or AI. For a traditional in vitro diagnostic assay like this, there isn't a "training set" in that sense. The assay's parameters (reagent concentrations, reaction conditions) are developed through chemical and biochemical optimization, often involving many experiments, but not a formally defined "training set" of patient data as would be found in AI/ML development.

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

As there is no "training set" in the context of AI/ML for this device, this question is not applicable. The "ground truth" for the development of reagent formulations and assay conditions would be based on established biochemical principles, analytical chemistry standards, and experimental results aimed at optimizing the reaction kinetics and stability.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal or logo with the text "Wiener lab." around the top and "SISTEMA DE CALIDAD CERTIFICADO" around the bottom. In the center of the seal, there is a stylized "W" symbol above the text "ISO 9001" and "TUV" below it. The seal appears to be a certification mark, possibly indicating that Wiener lab. has a quality management system certified to ISO 9001 standards by TUV.

Image /page/0/Picture/2 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller, sans-serif font.

WIENER LABORATORIOS S.A.I.C. - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: http://www.wiener-lab.com.ar

Section 6 - Summary

DEC 0 9 2002

510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"

"The assigned 510(k) number is: トのみるら5 / #

Introduction According to the requirements of 21 CFR 862.1100, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.

6-1 SubmitterName, Address,Contact	Wiener Laboratorios S.A.I.C.Riobamba 29442000 - Rosario - ArgentinaTel: 54 341 4329191Fax: 54 341 4851986Contact person: Viviana CétolaDate Prepared: September 02, 2002
6-2 Device Name	Proprietary name: Wiener lab. GOT (AST) UV AA Líquida.Common name: Aspartate aminotransferase (AST/SGOT) testsystem.Classification name: NADH Oxidation / NAD Reduction, AST /SGOT.Device Class II

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6-3 Predicate Device	We claim substantial equivalence to the currently marketed Wiener lab. GOT (AST) UV (Cat. N°1751302).
6-4 Device Description	Kinetic Method.
	The principle is based on the following reaction system:GOT (AST)
	L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate
	MDH
	Oxalacetate + NADH + H + → L-Malate + NAD +
	The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST).
	AST or GOT: Aspartate Aminotransferase.MDH: Malate Dehydrogenase.NADH: Nicotinamide-Adenine Dinucleotide (Reduced)NAD + : Nicotinamide-Adenine Dinucleotide.H + : Proton.
6-5 Intended Use	The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

6-6 Equivalencies The WIENER LAB. GOT (AST) UV AA Líquida test system is substantially equivalent to other products in commercial and Differences distribution intended for similar use. Most notably it is substantially equivalent to the currently WIENER LAB. GOT (AST) UV test system.
The following table illustrates the similarities and differences between the WIENER LAB. GOT (AST) UV AA Líquida test system and the currently marketed WIENER LAB. GOT (AST) UV test system.

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	GOT (AST) UV	GOT (AST) UV AALíquida
Intended Use	Quantitative determination of AspartateAminotransferase in human serum and plasma.
Test Principle	Kinetic Method.The principle is based on the following reactionsystem:L-aspartate + 2-oxoglutarateGOT (AST)Oxaloacetate + L-glutamateOxalacetate + NADH + H+MDHL-Malate + NAD+The rate of disappearance of NADH and the resultingdecrease in absorbance at 340 nm is directlyproportional to the activity of GOT (AST).AST or GOT: Aspartate Aminotransferase,MDH: MalateDehydrogenase, NADH: Nicotinamide-AdenineDinucleotide (Reduced), NAD+: Nicotinamide-AdenineDinucleotide, H+: Proton.
Reagents	Buffer: L-aspartate - TRIS (buffer)Substrate: NADH – MDH – LDH - 2-oxoglutarate
Preparation ofWorking Reagent	Dissolution of Reagentwith stated volume ofBuffer.	Reagents may be usedseparately or asMonoreagent, mixing 4parts Buffer and 1 partSubstrate.
Wavelength ofReading	334 - 340 - 366 nm	340 nm
Linearity	470 U/l	700 U/l
Expected values	Male: up to 38 U/l (37°C)Female: up to 32 U/l (37°C)
		Continued on next page
	GOT (AST) UV	GOT (AST) UV AALíquida
Within-runprecision	Normal Level Serum:CV = 4.4%High Level Serum:CV = 1.3%	Normal Level Serum:CV = 2.41%High Level Serum:CV = 1.22%
Run-to-runprecision	Normal Level Serum:CV = 4.9%High Level Serum:CV = 1.6%	Normal Level Serum:CV = 2.26%High Level Serum:CV = 2.16%

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6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.

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.DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.

: Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S.A.I.C: Riobamba 2944 2000 - Rosario - Argentina

K023551 Trade/Device Name: Wiener Lab. GOT (AST) UV AA Liquida Regulation Number: 21 CFR § 862.1100 Regulation Name: NADH Oxidation/NAD Reduction, AST/SGOT Regulatory Class: II Product Code: CIT Dated: September 13. 2002 Received: October 22, 2002

Dear Dr. Cetola:

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). 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.

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Page 2

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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html,

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K023551
Device Name:	Wiener lab.
	GOT (AST) UV AA LIQUIDA

Page ___ of ___Indications For Use:

The "Wiener lab. GOT (AST) UV AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109)

Over-The-Counter Uso__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -2:16

SK33
CH
II

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.