WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA

K023550 · Wiener Laboratories Saic · KNK · Dec 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023550
• Device Name: WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
• Applicant: Wiener Laboratories Saic
• Product Code: KNK · Clinical Chemistry
• Decision Date: Dec 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended 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.

Device Story

In vitro diagnostic test system for quantitative uric acid measurement in human serum and heparinized plasma; used in clinical laboratories on manual or automated systems. Principle: enzymatic colorimetric end-point method. Uricase (UOD) oxidizes uric acid to allantoin, hydrogen peroxide, and CO2; peroxidase (POD) catalyzes reaction of H2O2 with 4-aminophenazone and 3,5-dichlorohydroxybenzenesulfonic acid to form a red quinonimine pigment. Absorbance of pigment measured via spectrophotometer or photocolorimeter (490-530 nm) to determine uric acid concentration. Healthcare providers use results to diagnose/monitor renal and metabolic disorders, including gout and renal failure. Benefits include rapid, accurate assessment of uric acid levels to guide clinical management.

Clinical Evidence

Bench testing only. Precision studies compared within-run and run-to-run performance. Within-run CV: 2.21% (normal), 1.32% (high). Run-to-run CV: 2.86% (normal), 1.90% (high). No clinical patient studies provided.

Technological Characteristics

Enzymatic colorimetric assay. Reagents: Uricase, Peroxidase, 4-aminophenazone, 3,5-dichlorohydroxybenzenesulfonic acid, Good buffer. Liquid format, usable as monoreagent or separate reagents. Manual or automated system compatibility. Measurement wavelength: 490-530 nm.

Indications for Use

Indicated for quantitative determination of uric acid in human serum and heparinized plasma for diagnosis and treatment of renal and metabolic disorders (e.g., renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, cytotoxic drug therapy).

Regulatory Classification

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.

Predicate Devices

• Wiener lab. Uricostat enzimático AA test system (Cat. Nº 1840106)

Submission Summary (Full Text)

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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 [phone] - Fax [phone]/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: [phone] Fax: [phone] 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 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>Wiener lab. Uricostat enzimático AA test system (Cat. Nº<br>1840106). | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 6-4 Device<br>Description | End point method. | |
| | The principle is based on the following reaction system: | |
| | UOD<br>Uric Acid + 2 H2O + O2-<br>-> Allantoin + H2O2 + CO2<br>POD<br>2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------<br>The amount of uric acid is determined by measuring the<br>absorbance of this pigment.<br>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 is<br>a quantitative in vitro diagnostic device intended to be used in<br>the determination of uric acid in human sera and heparinized<br>plasmas on both manual and automated systems.<br>Measurements of serum uric acid, are used in the diagnosis<br>and treatment of numerous renal and metabolic disorders,<br>including renal failure, gout, leukemia, psoriasis, starvation or<br>other wasting conditions and of patients under treatment with<br>cytotoxic drugs. | |
| and Differences | 6-6 Equivalencies The Uricostat enzimático AA Líquida test system is substantially<br>equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the<br>currently marketed Uricostat enzimático AA test system.<br>The following table illustrates the similarities and differences<br>between the Uricostat enzimático AA Líquida test system and<br>the currently marketed Uricostat enzimático AA test system. | |
| | Uricostat enzimático<br>AA | Uricostat enzimático<br>AA Líquida |
| Intended Use | Enzymatic method for<br>the determination of uric<br>acid in serum or urine. | Enzymatic method for<br>the determination of uric<br>acid in serum or plasma. |
| Test Principle | End point method.<br><br>The analytical system is based on the following<br>reaction:<br>$Uric Acid + 2 H2O + O2$<br>UOD<br>$Allantoin + H2O2 + CO2$<br>$2 H2O2 + 4-AP + 3,5-DHS$<br>POD<br>red quinonimine<br>The amount of uric acid is determined by measuring<br>the absorbance of this pigment.<br>UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone;<br>3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt. | |
| Reagents | Standard: uric acid.<br>Buffer: phosphates<br>buffer.<br>Enzymes: UOD – POD –<br>DHS – 4-AP –<br>Potassium Ferrocyanide. | Standard: uric acid.<br>Reagent 1: Good buffer -<br>DHS.<br>Reagent 2: Good buffer -<br> |
| Preparation of<br>Working Reagent | Dissolution of an Enzyme<br>vial in a Buffer bottle. | Reagents may be used<br>separately or as<br>Monoreagent, mixing 4<br>parts of Reagent 1 + 1<br>part of Reagent 2. |
| Continued on next page | | |
| | Uricostat enzimático<br>AA | Uricostat enzimático<br>AA Líquida |
| Stability of Final<br>Color | 30 minutes. | |
| Wavelength of<br>Reading | 505 nm in spectrophotometer or 490-530 nm in<br>photocolorimeter with green filter. | |
| Calibration | Single point. | |
| Linearity | 20 mg/dl | |
| Within-run<br>precision | Normal Control:<br>CV = 1.75%<br>Abnormal Control:<br>CV = 1.78% | Normal Level Serum:<br>CV = 2.21%<br>High Level Serum:<br>CV = 1.32% |
| Run-to-run<br>precision | Normal Control:<br>CV = 2.61%<br>Abnormal Control:<br>CV = 2.39% | Normal Level Serum:<br>CV = 2.86%<br>High Level Serum:<br>CV = 1.90% |

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

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| | of_ |
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| 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)

OR

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 [phone]. 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 [phone] or [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 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

OR

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