WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311

K013095 · Wiener Laboratories Saic · CEO · Nov 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013095
• Device Name: WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
• Applicant: Wiener Laboratories Saic
• Product Code: CEO · Clinical Chemistry
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The FOSFATEMIA UV AA test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Device Story

In vitro diagnostic test system; measures inorganic phosphorus in serum, plasma, and urine samples. Principle of operation: end-point colorimetric method; inorganic phosphate reacts with molybdate in acidic environment to form phosphomolybdate complex; measured photometrically at 340 nm. Used in clinical laboratory settings by trained personnel. Output is a quantitative phosphorus concentration value; assists clinicians in diagnosing and monitoring metabolic, parathyroid, and renal disorders.

Clinical Evidence

Bench testing only. Comparison of performance characteristics against predicate device provided, including linearity (16 mg/dl), minimum detection limit (0.11 mg/dl), and color stability (20 minutes). No clinical trial data presented.

Technological Characteristics

In vitro diagnostic reagent system. Principle: Photometric end-point assay at 340 nm. Reagents: Sulfuric acid and ammonium molybdate. Working temperature: 25–37°C. Linearity: 16 mg/dl. Detection limit: 0.11 mg/dl. Manual or automated photometric analysis.

Indications for Use

Indicated for quantitative in vitro measurement of inorganic phosphorus in serum, plasma, and urine to assist in the diagnosis and treatment of parathyroid gland disorders, kidney diseases, and vitamin D imbalance.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system (Cat. Nº 836281)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the text "Warner lab." around the top edge of the circle. Inside the circle are the words "ISO 9001" stacked on top of each other. Below that is the word "TUV" above the word "CERT", with two curved lines above and below the words "TUV" and "CERT".

NOV 1 6 2001

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 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. - Rishamba 2944 - 2008 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"

y "The assigned 510(k) number is: _గం)3095

According to the requirements of 21 CFR 862.1580, the following Introduction 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: July 25, 2001
Proprietary name: Wiener lab. FOSFATEMIA UV AA 6-2 Device Name

Common name: Phosphorus (inorganic) test system

Classification name: Phosphomolybdate (Colorimetric), Inorganic Phosphorus, CEO, as per 21 CFR section 862.1580.

Device Class I

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| 6-3 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP.<br>INORGANIC PHOSPHORUS test system (Cat. Nº 836281) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-4 Device<br>Description | End point method. |
| | Inorganic phosphate reacts with molybdate in the presence of<br>acid to form a phosphomolybdate complex that is measured<br>photometrically at 340 nm. |
| 6-5 Intended Use | The FOSFATEMIA UV AA test system is a device intended to<br>measure inorganic phosphorus in serum, plasma and urine.<br>Measurements of phosphorus (inorganic) are used in the<br>diagnosis and treatment of various disorders, including<br>parathyroid gland and kidney diseases, and vitamin D<br>imbalance. |
| and Differences | 6-6 Equivalencies The Wiener lab. Inorganic Phosphorus test system is<br>substantially equivalent to other products in commercial<br>distribution intended for similar use. Most notably it is |

distribution intended for similar use. Most substantially equivalent to the currently marketed ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.

The following table illustrates the similarities and differences between the Wiener lab. Inorganic Phosphorus test system and currently marketed ROCHE DIAGNOSTICS / the the BOEHRINGER PHOSPHORUS test system.

| ROCHE/BOEHRINGER<br>Test System | WIENER LAB.<br>Test System | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | Method for measurement of inorganic phosphorus. | |
| | ROCHE/BOEHRINGER<br>Test System | WIENER LAB.<br>Test System |
| Test Principle | End point method.<br>Inorganic phosphate reacts with molybdate in the<br>presence of sulfuric acid to form a<br>phosphomolybdate complex that is measured<br>photometrically at 340 nm. | |
| Essential<br>Components | Ammonium molybdate - Sulfuric acid | |
| Reagents | R1: Sulfuric acid and<br>detergent.<br>R2: Sulfuric acid, Ammonium<br>molybdate and Sodium<br>chloride. | R: Sulfuric acid and<br>Ammonium molybdate. |
| Instability or<br>Deterioration<br>of Reagents | Not specified | Absorbance of<br>Reagent > 0.500. |
| Working<br>Temperature<br>Range | 25 – 37°C | |
| Stability of<br>Final Color | Not specified | 20 minutes |
| Wavelength of<br>Reading. | 340 nm | |
| Calibration | Single point | |
| Linearity | 20 mg/dl | 16 mg/dl |
| Minimum<br>Detection<br>Limit | Not specified | 0.11 mg/dl |

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and the same of the state of the county of

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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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

Dr. Viviana Cétola QC/QA Manager Wiener Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe Argentina

Re: K013095

> Trade/Device Name: Wiener Lab. Fosfatemia UV AA Test System Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) Test System Regulatory Class: I Product Code: CEO Dated: August 13, 2001 Received: September 17, 2001

Dear Dr. Cétola:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 1 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

K013095.

## NOV 1 6 2001

| 8<br>ge<br>C<br>C | C<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 510(k) Number (if known): | K013095 |
|---------------------------|------------------|
| Device Name: | Wiener lab. |
| | Fosfatemia UV AA |

Indications For Use:

The "Wiener lab. Fosfatemia UV AA" test system is a quantitative in vitro diagnostic device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

| (Division Sign-Off) | |
|---------------------------|---------|
| Division of Clinical Labo | Aces |
| 510(k) Number | K013095 |

RECEIVED

FDA/CORE/ODE/C

SEP 17 12 20 PM 0.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use بـ

(Optional Format 1-2-96)

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