WIENER LAB. BILIRUBINA DIRECT AA

K024116 · Wiener Laboratories Saic · CIG · Feb 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024116
• Device Name: WIENER LAB. BILIRUBINA DIRECT AA
• Applicant: Wiener Laboratories Saic
• Product Code: CIG · Clinical Chemistry
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The WIENER LAB. BILIRRUBINA DIRECTA AA test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct billirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Story

In vitro diagnostic test system for direct bilirubin measurement in human serum and heparinized plasma; used in clinical laboratories on manual or automated systems. Principle: direct bilirubin reacts with stable dichlorophenyldiazonium salt (DPD) in acid solution to form red azocompound; absorbance measured at 546 nm (spectrophotometer) or 520-550 nm (photocolorimeter). Amount of direct bilirubin proportional to pigment absorbance. Healthcare providers use results to diagnose/monitor liver, hemolytic, hematological, and metabolic disorders. Benefits include rapid, quantitative assessment of bilirubin levels to guide clinical management of hepatic and biliary conditions.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (within-run and total-run) comparing subject device to predicate. Within-run precision: Normal (CV 4.03%), High (CV 1.33%). Total-run precision: Normal (CV 5.09%), Abnormal (CV 2.00%). Linearity established up to 14 mg/dl.

Technological Characteristics

Diazo colorimetry test system. Reagents: R1 (sulfamic acid), R2 (dichlorophenyldiazonium salt), and sample blank (sulfamic acid). Measurement principle: spectrophotometric absorbance at 546 nm or photocolorimetric (520-550 nm). Linearity: 14 mg/dl. Compatible with manual and automated clinical laboratory systems.

Indications for Use

Indicated for quantitative determination of direct bilirubin in human serum and heparinized plasma to aid in diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder block).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• DMA Direct Bilirubin Plus test system (Cat. Nº1225)

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 "ISO 9001" above the letters "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 font.

IENER LABORATORIO Phone [phone]

2 2003

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:_YDAH || ج

| Introduction | According to the requirements of 21 CFR 862.1110, the following information provides sufficient details to understand the basis of a determination of substantial equivalence. |
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| 6-1 Submitter<br>Name, Address,<br>Contact | Wiener Laboratorios S.A.I.C.<br>Riobamba 2944<br>2000 - Rosario - Argentina<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Viviana Cétola<br>Date Prepared: September 15, 2002 |
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| 6-2 Device Name | Proprietary name: Wiener lab. BILIRRUBINA DIRECTA AA<br><br>Common name: Bilirubin (total or direct) test system<br><br>Classification name: Diazo colorimetry Bilirubin |

Device Class II

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- 6-3 Predicate We claim substantial equivalence to the currently marketed DMA Direct Bilirubin Plus test system (Cat. Nº1225). Device
- 6-4 Device Direct bilirubin is measured using a stable dichloro-Description phenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm.

The amount of direct bilirubin is determined by measuring the absorbance of this pigment.

- 6-5 Intended Use The WIENER LAB. BILIRRUBINA DIRECTA AA test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct billirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
- 6-6 Equivalencies The WIENER LAB. BILIRRUBINA DIRECTA AA test system is and Differences substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed DMA Direct Bilirubin Plus test system.

The following table illustrates the similarities and differences between the WIENER LAB. Bilirrubina Directa AA test system and the currently marketed DMA Direct Bilirubin Plus test svstem.

| | DMA<br>Test System | WIENER LAB.<br>Test System |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative<br>determination of direct<br>bilirubin in human serum. | Quantitative<br>determination of direct<br>bilirubin in human serum<br>and heparinized plasma. |
| | | Continued on next page |
| | DMA<br>Test System | WIENER LAB.<br>Test System |
| Test Principle | Conjugated billirubin<br>reacts with diazotized<br>sulfanilic acid to produce<br>an acid azobilirubin, the<br>absorbance of which is<br>proportional to the<br>concentration of direct<br>bilirubin in the sample<br>can be measured at 550<br>nm. | Direct bilirubin is<br>measured using a stable<br>dichlorophenyldiazonium<br>salt (DPD) to form a red<br>azocompound in an acid<br>solution, with maximal<br>O.D. at 546 nm. The<br>amount of direct bilirubin<br>is determined by<br>measuring the<br>absorbance of this<br>pigment. |
| Reagents | Bilirubin Reagent:<br>hydrochloric acid and<br>sulfanilic acid.<br>Sodium Nitrite Reagent:<br>sodium nitrite. | R1: sulfamic acid.<br>R2: dichlorophenyl-<br>diazonium salt.<br>Reagent for sample<br>blank: sulfamic acid. |
| Sample | Human serum. | Human serum and<br>heparinized plasma. |
| Wavelength of<br>Reading | 550 nm | Spectrophotometer:<br>546 nm<br>Photocolorimeter with<br>green filter:<br>520 - 550 nm |
| Linearity | 12 mg/dl | 14 mg/dl |
| Expected<br>values | | 0.0 — 0.2 mg/dl |
| | | Continued on next page |
| | DMA<br>Test System | WIENER LAB.<br>Test System |
| Within-run<br>precision | Normal Level Serum:<br>CV = <1% | Normal Level Serum:<br>CV = 4.03% |
| | High Level Serum:<br>CV = 2.8% | High Level Serum:<br>CV = 1.33% |
| Total-run<br>precision. | Normal Serum Control:<br>CV = 8.8%% | Normal Serum Control:<br>CV = 5.09% |
| | Abnormal Serum Control:<br>CV = 4.4% | Abnormal Serum Control:<br>CV = 2.00% |

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

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the head and wings of the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 2 2003

Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Rosario, Santa Fe Argentina 2000

Re: k024116 Trade/Device Name: Weiner Labs Bilirrubina directa AA Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: November 26, 2002 Received: December 13, 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).

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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.

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). You may obtain other general information on your responsibilities under the Act 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 Sutman

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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| Page of | __________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| 510(k) Number (if known): | K024146 |
|---------------------------|------------------------|
| Device Name: | Wiener lab. |
| | Bilirrubina directa AA |

Indications For Use:

The "Wiener lab. Bilirrubina directa AA" test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver. hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Ter 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

tan Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 241 510(k) Number _ 11