The “Wiener lab. Glicemia enzimática AA” test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

End point method. The Wiener lab. Glicemia enzimatica AA is based on the following reaction system: Glucose + O2 + H2O -> GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate -> POD red. The amount of glucose is determined by measuring the absorbance of this pigment. GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone).

AI/ML Overview

The provided text describes the "Wiener lab. Glicemia enzimática AA" test system, which is intended for the quantitative determination of glucose in human serum and plasma. The document highlights its substantial equivalence to a predicate device, the DMA GLUCOSE (Oxidase) test system.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document draws a comparison between the predicate device (DMA Test System) and the subject device (WIENER LAB. Test System). While it doesn't explicitly state "acceptance criteria" for the Wiener lab. device, it implicitly compares its performance parameters to those of the predicate device, suggesting that meeting or being comparable to the predicate's performance constitutes acceptance.

Parameter	DMA Test System Performance	WIENER LAB. Test System Performance
Intentional Use	Quantitative determination of glucose in human serum and plasma.	Quantitative determination of glucose in human serum and plasma.
Test Principle	End point method. Reaction system: Glucose + O2 + H2O →GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate →POD red quinonimine	End point method. Reaction system: Glucose + O2 + H2O →GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate →POD red quinonimine
Essential Components	GOD - POD - Mutarotase - 4-AP - Hydroxybenzoate	GOD - POD - 4-AP - Hydroxybenzoate
Calibrator and Serum Controls	Available - provided separately	Available - provided separately
Instability/Deterioration	Blank Absorbance > 0.300. Abnormal values of controls.	Blank Absorbance > 0.160. Abnormally low Standard Absorbance.
Sample	Human serum, heparinized plasmas, potassium oxalate/fluoride and EDTA/fluoride plasmas	Human serum, heparinized plasmas, potassium oxalate/fluoride and EDTA/fluoride plasmas
Working Temperature Range	37°C	Manual: 15 - 37°C; Automated: 37°C
Stability of final color	Not specified	30 minutes
Wavelength of reading	505 nm	505 nm
Calibration	Single point	Single point
Linearity	1000 mg/dl	500 mg/dl
Minimum detection limit	1.4 mg/dl	0.544 mg/dl
Expected values	75 - 113 mg/dl (70 - 105 mg/dl)	70 - 110 mg/dl (70 - 105 mg/dl)
Intra-assay precision	Normal Serum Control: CV = 0.66%; Abnormal Serum Control: CV = 0.58%	Normal Serum Control: CV = 1.39%; Abnormal Serum Control: CV = 1.11%
Inter-assay precision	Normal Serum Control: CV = 1.22%; Abnormal Serum Control: CV = 0.91%	Normal Serum Control: CV = 1.92%; Abnormal Serum Control: CV = 1.62%
Sterility conditions	Not required	Not required

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set in terms of patient samples. It provides performance characteristics (e.g., precision, linearity, detection limit) that would have been derived from testing, but the specifics of how many samples were used for these evaluations are not detailed.

The data provenance is not explicitly mentioned as country of origin, however, the submitter, Wiener Laboratorios S.A.I.C., is located in Rosario, Argentina. It’s not specified if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given text. The document is for an in vitro diagnostic device, and ground truth in this context generally refers to the true concentration of glucose in the samples, established through reference methods or highly accurate laboratory techniques, not typically by expert interpretation as in imaging studies.

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

This information is not applicable and therefore not provided, as the device is an in vitro diagnostic for quantitative measurement of glucose, not an AI imaging interpretation system that would require expert adjudication of results.

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 information is not applicable and therefore not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation plays a role. This document concerns a chemical assay for glucose measurement, which does not involve human readers in the output interpretation in the same way.

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

The device described, "Glicemia enzimatica AA," is a chemical assay test system. Its outputs are quantitative measurements of glucose. As such, it operates in a "standalone" fashion, providing a direct numerical result without human intervention for interpretation of the result itself (though a human performs the test and uses the result). The performance characteristics listed (precision, linearity, detection limit) directly reflect the algorithm/assay's standalone performance.

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

For an in vitro diagnostic device measuring glucose, the "ground truth" would typically be established based on:

Reference methods: Highly accurate and precise analytical methods for glucose determination (e.g., isotope dilution-mass spectrometry, hexokinase reference method).
Certified reference materials: Samples with known, validated glucose concentrations.

The document does not explicitly state the specific reference method used to establish the ground truth for the samples tested, but it would involve laboratory-based analytical techniques to determine the true glucose concentrations.

8. The sample size for the training set:

This information is not provided in the document. For an in vitro diagnostic like this, the "training set" concept is typically not directly applicable in the same way it is for machine learning models. Performance is usually established through analytical validation studies (e.g., linearity, precision, interference studies) which involve testing a range of samples and concentrations, but these are not explicitly termed "training sets."

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

As mentioned in point 8, the concept of a "training set" with ground truth in the machine learning sense is not directly relevant here. Instead, the performance of such a device is established through validation against recognized analytical standards and reference methods as described in point 7. The document does not detail the specific methods used to establish the "ground truth" for the samples in the performance evaluation studies.

Summary

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DEC 21 2001

Image /page/0/Picture/1 description: The image is a circular logo or seal with the text "Wiener lab." at the top. Inside the circle, there is a symbol resembling an upside-down "W" above the text "ISO 9001". Below that, there is another logo with the text "TUV CERT". The text "SISTEMA DE CALIDAD CERTIFICADO" is written around the bottom half of the circle.

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 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

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: كـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Introduction

According to the requirements of 21 CFR 862.1580, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Laboratorios S.A.I.C. 1) Submitter Riobamba 2944 Name, 2000 - Rosario - Argentina Address, Tel: 54 341 4329191 Contact Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: June 04, 2001

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GLICEMIA LAB. WIENER 2) Device name Proprietary name: ENZIMATICA AA

Common name: Glucose test system.

Classification name: Glucose oxidase, glucose as per 21CFR section 862.1345.

Device Class II

Predicate Device

We claim substantial equivalence to the currently (DMA) Data Medical Associates, Inc. marketed GLUCOSE (Oxidase) test system.

Device description End point method.

The Wiener lab. Glicemia enzimatica AA is based on the following reaction system:

$$\text{Glucose} + \text{O}{2} + \text{H}{2}\text{O} \xrightarrow{\text{GOD}} \text{Gluconic Acid} + \text{H}{2}\text{O}{2}$$

$$2 \text{ H}{2}\text{O}{2} + \text{4-AP} + \text{4-Hydroxybenzoate} \xrightarrow{\text{POD}} \text{red}$$

The amount of glucose is determined by measuring the absorbance of this pigment

GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone).

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Intended use The GLICEMIA ENZIMATICA AA test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal including disorders hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

6) Equivalencies

The WIENER LAB. GLICEMIA ENZIMATICA AA test system is substantially equivalent to other products in Equivalorioloo of oyensial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed DMA GLUCOSE (oxidase) test system.

The following table illustrates the similarities and differences between the WIENER LAB. GLICEMIA ENZIMATICA AA test system and the currently marketed DMA GLUCOSA test system.

	DMATest System	WIENER LAB.Test System
Intended use	Quantitative determination of glucose inhuman serum and plasma.
Test principle	End point method.
	The principle is based on the followingreaction system:$Glucose+O2+H2O ⟶GOD Gluconic Acid +H2O2$ $2 H2O2+4-AP+4-Hydroxybenzoate ⟶POD red quinonimine$
EssentialComponents	GOD - POD -Mutarotase - 4-APHydroxybenzoate	GOD - POD - 4-APHydroxybenzoate

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11.000

Calibrator andSerum Controls	Available - provided separately
Instability ordeterioration ofreagents	Blank Absorbance> 0.300.	Blank Absorbance> 0.160.
	Abnormal values ofcontrols.	Abnormally lowStandardAbsorbance.
Sample	Human serum, heparinized plasmas,potassium oxalate/fluoride andEDTA/fluoride plasmas
WorkingTemperatureRange	37°C	Manual: 15 - 37°CAutomated: 37°C
Stability of finalcolor	Not specified	30 minutes
Wavelength ofreading.	505 nm
Calibration	Single point
Linearity	1000 mg/dl	500 mg/dl
Minimumdetection limit	1.4 mg/dl	0.544 mg/dl
Expected values	75 - 113 mg/dl(70 - 105 mg/dl)	70 - 110 mg/dl(70 - 105 mg/dl)
Intra-assayprecision	Normal SerumControl:CV = 0.66%	Normal SerumControl:CV = 1.39%
	Abnormal SerumControl:CV = 0.58%	Abnormal SerumControl:CV = 1.11%
Inter-assayprecision	Normal Serum Control:CV = 1.22%Abnormal Serum Control:CV = 0.91%	Normal Serum Control:CV = 1.92%Abnormal Serum Control:CV = 1.62%
	Sterilityconditions	Not required

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7) Conclusion

Above mentioned data show substantial equivalency to the predicate device. ・

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized, overlapping shapes that resemble a caduceus, a symbol often associated with healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

Dr. Viviana Cétola QC/QA Manager Weiner Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe, Argentina

Re: K011953

Trade/Device Name: Glicemia enzimatica AA Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: October 1, 2001 Received: October 9, 2001

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 10 more 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and it you finding of substantial equivalence of your device to a legally marketed nouncation. THE FDF Intention 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 1 II you desire specific across ic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-4500. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your respondiations on 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 Sutman

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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CORR UNE

510(k) Number (if known):	K011953
Device Name:	Wiener lab.
	Glicemia enzimática AA

Indications For Use:

The “Wiener lab. Glicemia enzimática AA” test system is intended to be The Wichel lub. Shoon a termination of glucose in human serum and both manual and automated Glucose systems. plasma on and treatment of the diagnosis measurements are used in diabetes carbohydrate metabolism disorders including mellitus, hypoglycemia, and of idiopathic neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Jean Cooper

(Division Sign-
Division of Clire Laboratory Devices
510(k) Numbe: Kol1953

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.