The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid, are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.

Device Description

End point method. The principle is based on the following reaction system: UOD Uric Acid + 2 H2O + O2- -> Allantoin + H2O2 + CO2 POD 2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------ The amount of uric acid is determined by measuring the absorbance of this pigment. UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.

AI/ML Overview

The provided document describes the Wiener lab. Uricostat enzimático AA Líquida, an in vitro diagnostic device for determining uric acid levels. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study demonstrating device performance in the context of clinical acceptance criteria typical for AI/ML-based medical devices.

Therefore, the requested information elements related to AI/ML device testing (such as ground truth, expert adjudication, MRMC studies, training set details) are not applicable or available in this document. The information provided outlines the analytical performance of the device.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document serves as a 510(k) summary, which establishes substantial equivalence to a predicate device. The performance claims are primarily based on equivalence to the predicate and analytical performance. Explicit "acceptance criteria" for clinical utility in the context of a new AI/ML device are not stated, but rather, performance metrics compared to the predicate device are presented.

Acceptance Criteria (Implied for Analytical Performance)	Reported Device Performance (Uricostat enzimático AA Líquida)
Intended Use	Enzymatic method for the determination of uric acid in serum or plasma.
Test Principle	End point method using Uricase and Peroxidase reactions, measuring absorbance of red quinonimine.
Reagents	Standard: uric acid.Reagent 1: Good buffer - DHS.Reagent 2: Good buffer. Reagents can be used separately or as Monoreagent (4 parts Reagent 1 + 1 part Reagent 2).
Preparation of Working Reagent	Reagents may be used separately or as Monoreagent, mixing 4 parts of Reagent 1 + 1 part of Reagent 2. (Predicate required dissolution of an enzyme vial in a buffer bottle).
Stability of Final Color	(Not specified for new device, predicate was 30 minutes. Implied similar or better.)
Wavelength of Reading	505 nm in spectrophotometer or 490-530 nm in photocolorimeter with green filter.
Calibration	Single point.
Linearity	20 mg/dl (This value represents the upper limit of linearity).
Within-run precision (CV)	Normal Level Serum: CV = 2.21%High Level Serum: CV = 1.32%
Run-to-run precision (CV)	Normal Level Serum: CV = 2.86%High Level Serum: CV = 1.90%

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the precision and linearity studies, nor does it provide details on the provenance of the samples (e.g., country of origin, retrospective or prospective). This information is typically found in detailed validation reports, not in a 510(k) summary focused on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a quantitative in vitro diagnostic test for measuring uric acid, not an AI/ML device requiring expert interpretation of complex data for ground truth establishment. Its performance is evaluated against reference methods or established analytical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML device requiring human adjudication of ground truth.

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 device is an analytical test that measures a biochemical parameter, not a system that assists human readers in interpreting images or data.

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

This refers to the inherent performance of the Uricostat enzimático AA Líquida test system itself. The precision and linearity data represent the standalone analytical performance of the device without human intervention in the result generation (though human operators would perform the assay).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an in vitro diagnostic device like this, "ground truth" would typically refer to:

Reference materials: Control sera with known concentrations of uric acid.
Reference methods: Comparison with a gold standard analytical method for uric acid measurement.
Known concentrations: Spiking samples with known amounts of uric acid for linearity studies.

The document implicitly uses these types of "ground truth" for its analytical performance claims (e.g., "Normal Control," "Abnormal Control," "Normal Level Serum," "High Level Serum" for precision, and implied known concentrations for linearity).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in that context. The development of the reagents and assay would have involved optimization, but not "training data" in the machine learning sense.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal with the text "Wiener lab." at the top and "Sistema de Calidad Certificado" at the bottom. In the center of the seal, there is a logo with the letters "W" inside a circle, followed by the text "ISO 9001" and the logo of "TUV". 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 a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name, there is the text "Especialidades para Laboratorios Clínicos" in a smaller 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: »

Introduction

According to the requirements of 21 CFR 862.1775, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Laboratorios S.A.I.C. 6-1 Submitter Name, Address, Riobamba 2944 Contact 2000 - Rosario - Argentina Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: September 02, 2002

6-2 Device Name Proprietary name: Wiener lab. Uricostat enzimático AA Líquida. Common name: Uric acid test system Classification name: Acid, uric, uricase (colorimetric) Device Class I

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6-3 PredicateDevice	We claim substantial equivalence to the currently marketedWiener lab. Uricostat enzimático AA test system (Cat. Nº1840106).
6-4 DeviceDescription	End point method.
	The principle is based on the following reaction system:
	UODUric Acid + 2 H2O + O2--> Allantoin + H2O2 + CO2POD2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------The amount of uric acid is determined by measuring theabsorbance of this pigment.UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone;
	3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
6-5 Intended Use	The Wiener lab. Uricostat enzimático AA Líquida. test system isa quantitative in vitro diagnostic device intended to be used inthe determination of uric acid in human sera and heparinizedplasmas on both manual and automated systems.Measurements of serum uric acid, are used in the diagnosisand treatment of numerous renal and metabolic disorders,including renal failure, gout, leukemia, psoriasis, starvation orother wasting conditions and of patients under treatment withcytotoxic drugs.
and Differences	6-6 Equivalencies The Uricostat enzimático AA Líquida test system is substantiallyequivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to thecurrently marketed Uricostat enzimático AA test system.The following table illustrates the similarities and differencesbetween the Uricostat enzimático AA Líquida test system andthe currently marketed Uricostat enzimático AA test system.
	Uricostat enzimáticoAA	Uricostat enzimáticoAA Líquida
Intended Use	Enzymatic method forthe determination of uricacid in serum or urine.	Enzymatic method forthe determination of uricacid in serum or plasma.
Test Principle	End point method.The analytical system is based on the followingreaction:$Uric Acid + 2 H2O + O2$UOD$Allantoin + H2O2 + CO2$$2 H2O2 + 4-AP + 3,5-DHS$PODred quinonimineThe amount of uric acid is determined by measuringthe absorbance of this pigment.UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone;3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
Reagents	Standard: uric acid.Buffer: phosphatesbuffer.Enzymes: UOD – POD –DHS – 4-AP –Potassium Ferrocyanide.	Standard: uric acid.Reagent 1: Good buffer -DHS.Reagent 2: Good buffer -
Preparation ofWorking Reagent	Dissolution of an Enzymevial in a Buffer bottle.	Reagents may be usedseparately or asMonoreagent, mixing 4parts of Reagent 1 + 1part of Reagent 2.
Continued on next page
	Uricostat enzimáticoAA	Uricostat enzimáticoAA Líquida
Stability of FinalColor	30 minutes.
Wavelength ofReading	505 nm in spectrophotometer or 490-530 nm inphotocolorimeter with green filter.
Calibration	Single point.
Linearity	20 mg/dl
Within-runprecision	Normal Control:CV = 1.75%Abnormal Control:CV = 1.78%	Normal Level Serum:CV = 2.21%High Level Serum:CV = 1.32%
Run-to-runprecision	Normal Control:CV = 2.61%Abnormal Control:CV = 2.39%	Normal Level Serum:CV = 2.86%High Level Serum:CV = 1.90%

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

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	Page__________________________________________________________________________________________________________________________________________________________________________
	of_

510(k) Number (if known):	K023550
Device Name:	Wiener lab.
URICOSTAT: ENZIMÁTICO AA LÍQUIDA

Indications For Use:

The "Wiener lab. Uricostat enzimático AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGB IF NBBDBD

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines above it.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Dr. Viviana Cetola . QC/QA Manager Wiener Laboratorios S.A.I.C. Riobamba 2944 2000 - Rosario - Argentina

K023550 Re:

Trade/Device Name: Wiener Lab. Uricostat enzimatico AA Liquida Regulation Number: 21 CFR § 862.1775 Regulation Name: Uric Acid, Uricase (Colorimetric) Regulatory Class: I Product Code: KNK 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 Butman

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):	K033550
Device Name:	Wiener lab.
	URICOSTAT: ENZIMÁTICO AA LIQUIDA

Indications For Use:

The "Wiener lab. Uricostat enzimático AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the, determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid are used in the diagnosis and treatment of numerous renal and , metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment. with cytotoxic drugs.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER. PAGB IF NBBOBD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Zion & Eph

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

Regulation Number and Section

§ 862.1775 Uric acid test system.

(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.