WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

K024305 · Wiener Laboratories Saic · JIX · Mar 18, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024305
• Device Name: WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
• Applicant: Wiener Laboratories Saic
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For the quantitative calibration of Wiener lab's clinical chemistry procedures. The "Calibrador A plus" is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Device Story

Calibrador A Plus is a lyophilized human serum-based multianalyte calibrator; contains specific concentrations of clinical chemistry analytes including albumin, bilirubin, calcium, cholesterol, creatinine, glucose, iron, magnesium, phosphorus, proteins, triglycerides, urea, and uric acid. Used in clinical laboratories to establish reference points for quantitative calibration of Wiener Lab clinical chemistry test systems. Product is reconstituted by laboratory personnel; concentrations are lot-specific. Provides standardized reference values to ensure accuracy of patient specimen measurements; facilitates clinical decision-making by ensuring reliable diagnostic test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum matrix; multianalyte mixture. Formulated to contain specific concentrations of clinical chemistry analytes. Reconstituted for use. No electronic, software, or mechanical components.

Indications for Use

Indicated for the quantitative calibration of clinical chemistry procedures in human specimens. Intended for use by clinical laboratory professionals.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• ROCHE Calibrator for Automated systems (C.f.a.s.) (Cat. Nº759350)

Submission Summary (Full Text)

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MAR 1 8 2003

Calibrador A Plus Wiener lab.

Image /page/0/Picture/2 description: The image is a circular seal or logo, likely representing a certification or quality standard. The text "Wiener lab." appears at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is written along the bottom. In the center of the seal, "ISO 9001" is prominently displayed above a logo that includes the letters "TUV".

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 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: _ K 0 % 4 305 33

According to the requirements of 21 CFR 862.1150, the following Introduction 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: September 15, 2002 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | Proprietary name: Wiener lab. Calibrador A Plus.<br>Common name: Multianalyte Calibrator.<br>Classification name: Calibrator, Multi-Analyte Mixture.<br>Device Class II |

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- 6-3 Predicate We claim substantial equivalence to the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.) (Cat. Device Nº759350).
Calibrador A plus consists of Ivophilized human serum 6-4 Device Description containing the compounds usually determined in clinical chemistry laboratories in the appropriate concentrations to ensure optimum calibration of clinical chemistry procedures. Such concentrations are lot-specific and are provided in product insert.

For the quantitative calibration of WIENER LAB's clinical 6-5 Intended Use chemistry procedures. Calibrador A plus is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

The WIENER LAB. Calibrador A Plus calibrator is substantially 6-6 Equivalencies equivalent to other products in commercial distribution intended and Differences for similar use. Most notably it is substantially equivalent to the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.)

> The following table illustrates the similarities and differences between the WIENER LAB. Calibrador A Plus calibrator and the currently marketed ROCHE Calibrator for Automated systems (C.f.a.s.)

| | ROCHE<br>C.f.a.s. | WIENER LAB.<br>Calibrador A Plus |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration<br>of Roche methods on<br>clinical chemistry<br>analyzers. | For the quantitative<br>calibration of WIENER<br>LAB's clinical chemistry<br>procedures. |
| Format | Lyophilized pooled human sera with constituents<br>added as required to obtain desired components<br>levels. | |
| Continued on next page | | |
| | ROCHE<br>C.f.a.s. | WIENER LAB.<br>Calibrador A Plus |
| Stability | Provided Reagents: stable in refrigerator (2-10°C)<br>until expiration date printed on label.<br>Reconstituted calibrator: stable for 8 hours at room<br>temperature, 2 days refrigerated or 1 month frozen<br>(-20°C), with exceptions noted in label. | |
| Levels | Single Level. | |
| | Albumin | Albumin |
| | Direct bilirubin | Direct bilirubin |
| | Total bilirubin | Total bilirubin |
| | Calcium | Calcium |
| | Cholesterol | Cholesterol |
| | Creatinine | Creatinine |
| | HDL Cholesterol | HDL Cholesterol |
| Constituent<br>Analytes | Glucose | Glucose |
| | Iron | Iron |
| | Magnesium | Magnesium |
| | Phosphorus | Phosphorus |
| | Total proteins | Total proteins |
| | Triglycerides | Triglycerides |
| | Uric acid | Uric acid |
| | Urea | Urea |
| | Enzymes | |
| | Electrolytes | |

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Above mentioned data show substantial equivalency to the 6-7 Conclusion 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, composed of three curved lines that suggest wings and a head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 2003

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

Re: k024305

Trade/Device Name: Weiner lab. Calibrador A plus Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 13, 2002 Received: December 24, 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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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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CDRH ODE

| Page | of____________________________________________________________________________________________________________________________________________________________________________ |
|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 510(k) Number (if known): | K024305 |
|---------------------------|-------------------|
| Device Name: | Wiener lab. |
| | Calibrador A plus |

Indications For Use:

- ·

For the quantitative calibration of Wiener lab's clinical chemistry procedures. The "Calibrador A plus" is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

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

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) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|

Iran Cooper

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K024305 |