WIENER LAB. UREA UV CINETICA AA

K012260 · Wiener Laboratories Saic · CDQ · Sep 19, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012260
• Device Name: WIENER LAB. UREA UV CINETICA AA
• Applicant: Wiener Laboratories Saic
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The UREA UV CINETICA AA test system is intended to be used in the quantitative determination of urea in human serum and plasma. Urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

The Wiener lab. UREA UV CINETICA AA is an in vitro diagnostic test system for the quantitative determination of urea in human serum and plasma. The device utilizes a kinetic enzymatic method based on a two-step reaction: first, urease hydrolyzes urea into ammonia and carbon dioxide; second, glutamate dehydrogenase (GIDH) catalyzes the reaction of ammonia with 2-oxoglutarate and NADH to produce L-glutamate and NAD+. The decrease in absorbance, proportional to urea concentration, is measured at 340 nm. The test is performed in a clinical laboratory setting by trained personnel. Results assist clinicians in diagnosing and monitoring renal and metabolic conditions. The system offers improved reagent stability (30 days) and precision compared to the predicate.

Clinical Evidence

Bench testing only. Performance data compared the subject device to the predicate, including linearity (up to 300 mg/dl urea), detection limits (3.8 mg/dl urea), and precision. Intra-assay CVs were 2.01% (normal) and 1.19% (abnormal); inter-assay CVs were 2.36% (normal) and 1.31% (abnormal).

Technological Characteristics

Kinetic enzymatic assay using Urease and Glutamate Dehydrogenase (GIDH). Reagents include 2-oxoglutarate, NADH, Urease, and GIDH. Operates at 37°C. Photometric measurement at 340 nm. Manual or automated clinical chemistry analyzer compatible.

Indications for Use

Indicated for the quantitative determination of urea (urea nitrogen) in human serum and plasma for the diagnosis and treatment of renal and metabolic diseases. For prescription use.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Predicate Devices

• DMA BUN-KINETIC, UREASE PROCEDURE test system (Cat. Nº 1770)

Submission Summary (Full Text)

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SEP 1 9 2001

Image /page/0/Picture/2 description: The image is a circular seal with the words "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" around 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 "TUV CERT" logo. The seal appears to be a certification mark, possibly indicating that Wiener lab. has been certified to meet the ISO 9001 standard.

Image /page/0/Picture/3 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 font.

**WIENER LABORATORIOS S.A.I.C.** - Riobamba 2944 - 2000 Rosario - Argentina
Phone [phone] - Fax [phone]/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"

リ "The assigned 510(k) number is: ±(0)22400

According to the requirements of 21 CFR 862.1770, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Laboratorios S.A.I.C. 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Tel: [phone] Fax: [phone] Contact person: Viviana Cétola Date Prepared: June 23, 2001

6 - 1

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| 6-2 Device Name | Proprietary name: Wiener lab. UREA UV CINETICA AA<br>Common name: Urea test system |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification name: Urease and Glutamic Dehydrogenase,<br>Urea Nitrogen. |
| | Device Class II |
| 6-3 Predicate Device | We claim substantial equivalence to the currently marketed<br>DMA BUN-KINETIC, UREASE PROCEDURE test system (Cat.<br>Nº 1770). |
| 6-4 Device Description | Kinetic method. |
| | The device is based on the following reaction system:<br>Urease |
| | Urea + H2O --------> 2 NH3 + CO2 |
| | NH3 + NADH + H+ + 2-oxoglutarate --------> I-glutamate + NAD+<br>+ H2O |
| 6-5 Intended Use | The UREA UV CINETICA AA test system is intended to be<br>used in the quantitative determination of urea in human serum<br>and plasma. Urea measurements are used in the diagnosis and<br>treatment of certain renal and metabolic diseases. |
| 6-6 Equivalencies and Differences | The WIENER UREA UV CINETICA AA test system is<br>substantially equivalent to other products in commercial<br>distribution intended for similar use. Most notably it is<br>substantially equivalent to the currently marketed DMA BUN-<br>KINETIC, UREASE PROCEDURE test system. |
| | The following table illustrates the similarities and differences<br>between the WIENER UREA UV CINETICA AA test system and<br>the currently marketed DMA BUN-KINETIC, UREASE<br>PROCEDURE test system. |

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| | DMA Test System | WIENER LAB. Test<br>System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of urea in human<br>serum and plasma. | |
| Test Principle | Kinetic method.<br>The test is based on the following reaction<br>system:<br>Urease<br>Urea + H2O $\rightarrow$ 2 NH3 + CO2<br>NH3 + NADH + H+ + 2-oxoglutarate<br>GIDH<br>$\rightarrow$ I-glutamate + NAD+ + H2O | |
| Essential<br>Components | 2-Oxoglutarate - NADH - Urease - GIDH. | |
| Working Reagent<br>Stability | 14 days | 30 days |
| Instability or<br>deterioration of<br>reagents | Reagent Blank<br>Absorbance<br>< 1.100.<br>Precipitated or hazy<br>standard. | Reagent Blank<br>Absorbance<br><1.000. |
| Sample | Human serum, heparinized plasmas and<br>EDTA plasmas | |
| Working<br>Temperatures | 25 - 37°C | 37°C |
| Wavelength of<br>reading. | 340 nm | |
| Calibration | Single point | |
| Linearity | 100 mg/dl (BUN)<br>214 mg/dl (urea) | 140 mg/dl (BUN)<br>300 mg/dl (urea) |
| | DMA Test System | WIENER LAB. Test<br>System |
| Minimum detection<br>limit | 0.4 mg/dl (BUN)<br>0.9 mg/dl (urea) | 1.8 mg/dl (BUN)<br>3.8 mg/dl (urea) |
| Expected values | 8 - 23 mg/dl (BUN)<br>17 - 49 mg/dl | 4.7 - 23 mg/dl (BUN)<br>10 - 50 mg/dl (urea) |
| Intra-assay precision | Normal Serum<br>Control:<br>CV = 4.3%<br>Abnormal Serum<br>Control:<br>CV = 4.1% | Normal Serum Control:<br>CV = 2.01%<br>Abnormal Serum<br>Control:<br>CV = 1.19% |
| Inter-assay precision | Normal Serum<br>Control:<br>CV = 2.9%<br>Abnormal Serum<br>Control:<br>CV = 6.1% | Normal Serum Control:<br>CV = 2.36%<br>Abnormal Serum<br>Control:<br>CV = 1.31% |

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## 6-7 Conclusion The date above mentioned 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the public. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Viviana Cetola QA/QC Manager Weiner Laboratories S.A.I.C. Riobamba 2944 2000 - Rosairo - Argentina

Re: k012260

> Trade/Device Name: Urea UV Cinetica AA Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ Dated: July 4, 2001 Received: July 18, 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 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.

SEP 1 9 2001

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 w your 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 1 11 you desire specific and in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, [phone]. Tradition for Compliance at [phone]. 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 miormation on July 1981 1999 1199 11-19 1011-free number [phone] 01 [phone] 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 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): | K012260 |
|---------------------------|---------------------|
| Device Name: | Wiener lab. |
| | Urea UV.cinética AA |
| Indications For Use: | |

K012260

Page ___ of ___

FDA/CDRH/ODE/B.

JUL 18 4 32 PM '01

SK-27

The "Wiener lab. Urea UV cinética AA" urea test system is a device intended to measure urea (urea nitrogen) levels in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Alexander for Joan Coper

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)