WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553

K030482 · Wiener Laboratories · JJY · Mar 19, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030482
• Device Name: WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
• Applicant: Wiener Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The "Wiener lab. Standatrol S-E 2 niveles" is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.

Device Story

Standatrol S-E 2 niveles is a lyophilized human serum-based quality control material; contains various clinical chemistry analytes (substrates, electrolytes, lipids, enzymes, proteins). Used in clinical laboratories to estimate test precision; detect systematic analytical deviations caused by reagent or instrument variation; and for proficiency testing in interlaboratory surveys. Operates by providing known, lot-specific concentration ranges for comparison against patient sample results. Used by laboratory personnel on both manual techniques and automated clinical chemistry analyzers. Benefits include ensuring accuracy and precision of diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only; comparison of constituent analytes and stability profiles against predicate device.

Technological Characteristics

Lyophilized human serum; contains clinical chemistry analytes (e.g., albumin, bilirubin, cholesterol, enzymes, electrolytes). Stability: 2-10°C until expiration; reconstituted stability 5 days at 2-10°C or 1 month frozen (-20°C).

Indications for Use

Indicated for use as an assayed quality control material in clinical chemistry laboratories to monitor accuracy and precision of manual and automated analytical methods for substrates, electrolytes, lipids, enzymes, and proteins.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• ROCHE Precinorm U and Precipath U (K1446096)

Submission Summary (Full Text)

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MAR 1 9 2003

Standatrol S-E 2 niveles Wiener lab.

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 is a logo that looks like a "W" and the words "ISO 9001" and "TUV CERT". The seal appears to be a quality certification mark.

Image /page/0/Picture/3 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

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: ______________________________________________________________________________________________________________________________________________ ע

Introduction According to the requirements of 21 CFR 862.1660, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.

| 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: November 15, 2002 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | Proprietary name: Wiener lab. Standatrol S-E 2 niveles.<br>Common name: Quality Control Material (assayed and<br>unassayed).<br>Classification name: Multi-Analyte Controls, all kinds (assayed<br>and unassayed).<br>Device Class I |

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- We claim substantial equivalence to the currently marketed 6-3 Predicate ROCHE Precinorm U and Precipath U (Cat. Nº171735 and Device 1446096 ).
- Standatrol S-E 2 niveles consists of lyophilized human serum 6-4 Device containing the analytes usually determined in clinical chemistry Description laboratories. The exact concentrations and acceptable ranges of the components are lot-specific and are provided in the product insert.
- Standatrol S-E 2 niveles is a device intended for medical 6-5 Intended Use purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and

precision both for manual techniques and assays on automated clinical chemistry analyzers.

The WIENER LAB. Standatrol S-E 2 niveles is substantially 6-6 Equivalencies and Differences equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed ROCHE Precinorm U and Precipath U.

> The following table illustrates the similarities and differences between the WIENER LAB. Standatrol S-E 2 niveles quality control material and the currently marketed ROCHE Precinorm U and Precipath U.

| | ROCHE<br>Precinorm U and<br>Precipath U. | WIENER LAB.<br>Standatrol S-E<br>2 niveles |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For quality control in<br>the quantitative<br>determination of<br>substrates,<br>electrolytes, lipids,<br>enzymes and proteins. | Intended for use as<br>assayed control<br>material for automated<br>and manual clinical<br>chemistry methods. |
| | ROCHE<br>Precinorm U and<br>Precipath U. | WIENER LAB.<br>Standatrol S-E<br>2 niveles |
| Format | Lyophilized pooled human sera with<br>constituents added as required to obtain<br>desired components levels. | |
| Stability | Provided Reagents:<br>stable in refrigerator<br>(2-8°C) until expiration<br>date printed on label.<br>Reconstituted control<br>serum: stable for 12<br>hours at 25°C, 5 days<br>at 4°C or 1 month<br>frozen<br>(-20°C), with<br>exceptions noted in<br>label. | Provided Reagents:<br>stable in refrigerator<br>(2-10°C) until<br>expiration date printed<br>on label.<br>Reconstituted control<br>serum: stable for 5<br>days at 2 - 10°C or 1<br>month frozen (-20°C),<br>with exceptions noted<br>in label. |
| Levels | Two Levels. | |
| | Albumin | Albumin |
| | Bilirubin, Direct | Bilirubin, Direct |
| | Bilirubin, Total | Bilirubin, Total |
| | Calcium | Calcium |
| | Cholesterol | Cholesterol |
| | - | HDL-Cholesterol |
| | Chloride | Chloride |
| Constituent<br>Analytes and<br>Enzymes | Creatinine | Creatinine |
| | Glucose | Glucose |
| | Iron | Iron |
| | total Iron-binding<br>capacity | - |
| | Magnesium | Magnesium |
| | Inorganic Phosphorus | Inorganic Phosphorus |
| | Potassium | Potassium |
| | Protein, total | Protein, total |
| | Sodium | Sodium |
| | | Continued on next page |
| | ROCHE<br>Precinorm U and<br>Precipath U. | WIENER LAB.<br>Standatrol S-E<br>2 niveles |
| Constituent<br>Analytes and<br>Enzymes | Triglycerides | Triglycerides |
| | Urea | Urea |
| | Uric acid | Uric acid |
| | Alkaline Phosphatase | Alkaline Phosphatase |
| | α-Amylase | α-Amylase |
| | Alanine<br>Aminotransferase | Alanine<br>Aminotransferase |
| | Aspartate<br>Aminotransferase | Aspartate<br>Aminotransferase |
| | Cholinesterase | Cholinesterase |
| | Creatine Kinase | Creatine Kinase |
| | γ-Glutamyltransferse | γ-Glutamyltransferse |
| | Lactate<br>Dehydrogenase | Lactate<br>Dehydrogenase |
| | Other electrolytes | - |
| | Other enzymes | - |

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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 is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a series of flowing lines, creating a sense of movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2003

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

k030482 Re:

> Trade/Device Name: Weiner Lab. Standatrol S-E 2 niveles Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 30, 2002 Received: February 13, 2003

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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Page 2 -

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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K030482

Page_

| 510(k) Number (if known): | K030482 |
|---------------------------|--------------------------|
| Device Name: | Wiener lab. |
| | Standatrol S-E 2 niveles |

Indications For Use:

The "Wiener lab. Standatrol S-E 2 niveles" is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. It may also be used for proficiency testing in interlaboratory surveys.

This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

OR ...

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices In 19 36 510(k) Number -

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Over-The-Counter Use_

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