WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300

K012329 · Wiener Laboratories Saic · CIX · Sep 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012329
• Device Name: WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
• Applicant: Wiener Laboratories Saic
• Product Code: CIX · Clinical Chemistry
• Decision Date: Sep 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The WIENER LAB ALBUMINA AA test system is intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Story

In vitro diagnostic test system; utilizes bromcresol green (BCG) dye-binding method; input is human serum sample; albumin reacts with BCG to form colored complex; absorbance measured at 600-650 nm; increase in absorbance relative to reagent blank is proportional to albumin concentration; used in clinical laboratory settings; operated by laboratory technicians; output is quantitative albumin concentration; results assist clinicians in diagnosing and monitoring liver and kidney disease.

Clinical Evidence

Bench testing only. Performance data includes intra-assay precision (CV 2.10% normal, 2.48% abnormal) and inter-assay precision (CV 3.57% normal, 3.99% abnormal). Comparison provided against predicate device for linearity, sensitivity, and expected values.

Technological Characteristics

Bromcresol green (BCG) dye-binding colorimetric assay. Reagent-based chemistry. Photometric detection (600-650 nm). Standalone diagnostic test system for use with clinical analyzers.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of albumin in human sera to aid in diagnosis and treatment of liver or kidney diseases.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• ABBOTT ALBUMIN BCG test system

Submission Summary (Full Text)

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ALBUMINA AA Wiener lab.

SEP 2 1 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 "ISO 9001" above the letters "TUV CERT". The seal appears to be a certification mark, possibly indicating that the product or organization meets certain quality standards.

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"

"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________ 93

According to the requirements of 21 CFR 862.1580, 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: March 19, 2001

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| 6-2 Device Name | Proprietary name: WIENER LAB ALBUMINA AA<br>Common name: Albumin test system.<br>Classification name: Bromcresol Green Dye-Binding, Albumin<br>Device Class II |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-3 Predicate Device | We claim substantial equivalence to the currently marketed<br>ABBOTT ALBUMIN BCG test system. |
| 6-4 Device Description | Albumin reacts specifically with bromcresol green to produce a<br>colored complex. Increase of absorbance at 625 nm with<br>respect to the reagent Blank is proportional to the albumin<br>concentration in sample. |
| 6-5 Intended Use | The WIENER LAB ALBUMINA AA test system is intended to<br>be used in the quantitative determination of albumin in human<br>sera. Albumin measurements are used in the diagnosis and<br>treatment of numerous diseases involving primarily the liver or<br>kidneys. |
| 6-6 Equivalencies and Differences | The WIENER LAB ALBUMINA AA test system is substantially<br>equivalent to other products in commercial distribution<br>intended for similar use. Most notably it is substantially<br>equivalent to the currently marketed ABBOTT ALBUMIN BCG<br>test system.<br>The following table illustrates the similarities and differences<br>between the WIENER LAB ALBUMINA AA test system and<br>the currently marketed ABBOTT ALBUMIN BCG test system. |

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| | ABBOTT Test<br>System | WIENER LAB. Test<br>System |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Intended Use | Quantitative<br>determination of<br>albumin in human sera<br>and plasma. | Quantitative<br>determination of<br>albumin in human<br>sera. |
| Test Principle | Albumin reacts specifically with bromcresol<br>green (BCG) to produce a colored complex.<br>Increase of absorbance at 625 nm with respect<br>to the reagent Blank is proportional to the<br>albumin concentration in sample. | |
| Essential<br>Components | BCG | |
| Reagents | Single reagent ready to use | |
| Storage and<br>Stability of<br>Reagent | Stable until expiration date printed on the labels<br>when stored at room temperature | |
| Serum Controls | Available - provided separately | |
| Sample | Human sera and<br>plasmas | Human sera |
| Wavelength of<br>reading. | 600 nm | 600 to 650 nm |
| Linearity | up to 7 g/dl | |
| Minimum<br>Detection Limit | 0.1 g/dl | 0.02 g/dl |
| Analytical<br>sensitivity | 0.2 g/dl | 0.7 g/dl |
| | Continued on next page | |
| | ABBOTT Test<br>System | WIENER LAB. Test<br>System |
| Expected values | Male: 4.2-5.5 g/dl<br>Female: 3.7-5.3 g/dl<br>Hospitalized Adult: 3.5-<br>5.0 g/dl | 3.5 - 4.8 g/dl |
| Intra-assay<br>Precision | Normal Serum Control:<br>CV = 1.8 - 1.2 - 1.5%<br>Abnormal Serum<br>Control:<br>CV = 1.7-1.4-0.8%<br>(in different analyzers) | Normal Serum Control:<br>CV = 2.10 %<br>Abnormal Serum<br>Control:<br>CV = 2.48 % |
| Inter-assay<br>Precision | Normal Serum Control:<br>CV = 2.1 - 1.9 - 2.0 %<br>Abnormal Serum<br>Control:<br>CV = 2.3 - 2.2 - 1.6 %<br>(in different analyzers) | Normal Serum Control:<br>CV = 3.57 %<br>Abnormal Serum<br>Control:<br>CV = 3.99 % |

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## 6-7 Conclusion

Based on the data above mentioned, we believe that the extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes a stylized caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 2 1 2001

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

k012329 Re: Trade/Device Name: Albumina AA Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX Dated: July 16, 2001 Received: July 23, 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.

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 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CDRH ODE

| Page | of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| 510(k) Number (if known): | K012329 |
|---------------------------|---------------|
| Device Name: | Wiener lab. |
| | Albumina. AA. |

Indications For Use:

The "Wiener lab. Albumina AA" albumin test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Kusin Alexander for Sean Cooper*
(Division Sign
Division of Culatory Devices
510(k) number K012329

Prescription Use
(Per 21 CFR 801.109)

510(k) Number

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)