WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5

K021334 · Wiener Laboratories Saic · CJY · Sep 10, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021334
• Device Name: WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
• Applicant: Wiener Laboratories Saic
• Product Code: CJY · Clinical Chemistry
• Decision Date: Sep 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

The "Wiener lab. Ca-Color Arsenazo III AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).

Device Story

The Ca-Color Arsenazo III AA is an in vitro diagnostic reagent system for measuring calcium levels in human serum, heparinized plasma, and urine. The device utilizes a chemical reaction where calcium ions react with Arsenazo III to form a blue-colored complex. 8-hydroxyquinoline is included to eliminate magnesium interference. The resulting complex is measured photocolorimetrically at 650 nm. The system is designed for use on both manual and automated laboratory platforms. Healthcare providers use the resulting quantitative calcium measurements to assist in the diagnosis and clinical management of conditions such as parathyroid disorders, bone diseases, chronic renal disease, and tetany. The device provides a diagnostic tool for clinical laboratories to assess patient calcium status.

Clinical Evidence

Bench testing only. Performance data provided includes precision studies comparing within-run and run-to-run coefficients of variation (CV) for normal and high-level serum and urine samples. Within-run CVs for the subject device ranged from 0.88% to 2.57%, and run-to-run CVs ranged from 1.29% to 2.62%.

Technological Characteristics

In vitro diagnostic reagent system. Principle: Photocolorimetric measurement of a calcium-Arsenazo III complex at 650 nm. Includes 8-hydroxyquinoline for magnesium interference removal. Reagent storage: 2-10°C. Compatible with manual and automated laboratory systems.

Indications for Use

Indicated for the quantitative determination of calcium in human serum, heparinized plasma, and urine for the diagnosis and treatment of parathyroid diseases, bone diseases, chronic renal diseases, and tetany.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• WIENER LAB. CA-COLOR AA (Cat. No 1152002)

Submission Summary (Full Text)

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SEP 1 0 2002

Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a circular graphic on the left and the text "Wiener lab." on the right. Below the text is the phrase "Especialidades para Laboratorios Clinicos".

WIENER

## 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: _____________________________________________________________________________________________________________________________________________ y

| Introduction | According to the requirements of 21 CFR 862.1145, the<br>following information provides sufficient details to understand<br>the basis of a determination of substantial equivalence. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 6-1 Submitter<br>Name, Address,<br>Contact | Wiener Lab Group<br>Riobamba 2944<br>2000 - Rosario - Argentina<br>Contact person: Viviana Cétola<br>Date Prepared: July, 2002 | |
| 6-2 Device Name | Proprietary name: WIENER LAB. CA-COLOR ARSENAZO III<br>AA<br>Common name: Calcium test system.<br>Classification name: Azo Dye, Calcium<br>Device Class II | |
| 6-3 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>WIENER LAB. CA-COLOR AA (Cat. N o 1152002) kit. | |

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Calcium reacts with Arsenazo III, vielding a blue colored 6-4 Device complex, which is photocolorimetrically measured at 650 nm. Description 8-hydroxyquinoline is added to remove magnesium interference.

The WIENER LAB. CA-COLOR ARSENAZO III AA test 6-5 Intended Use system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).

The WIENER LAB. CA-COLOR ARSENAZO III AA test 6-6 Equivalencies and Differences system is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed WIENER LAB. CA-COLOR AA test system.

> The following table illustrates the similarities and differences between the WIENER LAB. CA-COLOR ARSENAZO III AA test system and the currently marketed WIENER LAB. CA-COLOR AA test system.

| | CA-COLOR AA | CA-COLOR<br>ARSENAZO III AA |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of calcium in human<br>serum, heparinized plasma and urine.<br>Continued on next page | |
| | CA-COLOR AA | CA-COLOR<br>ARSENAZO III AA |
| Test principle | Calcium reacts with o-<br>Cresolphtalein<br>complexone (o-CPC) at<br>pH 10.8, yielding a<br>purple colored complex,<br>which is<br>photocolorimetrically<br>measured at 570 nm.<br>8-hydroxyquinoline is<br>added to remove<br>magnesium<br>interference | Calcium reacts with<br>Arsenazo III, yielding a<br>blue colored complex,<br>which is<br>photocolorimetrically<br>measured at 650 nm.<br>8-hydroxyquinoline is<br>added to remove<br>magnesium<br>interference |
| Essential<br>Components | o-CPC<br>8-hydroxyquinoline | Arsenazo III<br>8-hydroxyquinoline |
| Reagent Storage | Room temperature | 2 - 10°C |
| Reagent<br>Deterioration | Reagent Blank > 0.400<br>O.D. | Reagent turbidity<br>Reagent Blank > 0.800<br>O.D. |
| Preparation of<br>Working Reagent | Mixture of R1 and R2<br>(1:1) or they can be<br>used separately. | None |
| Working Reagent<br>Stability | Stable 4 days at 2-10°C | Same as kit stability |
| Precautions | All glassware should be cleaned with diluted<br>hydrochloric acid and rinsed with distilled water. | |
| Working<br>Temperatures | Room temperature - 37°C | |
| Wavelength of<br>reading. | 560 - 590 nm | 620 - 650 nm |
| | | Continued on next page |
| | CA-COLOR AA | CA-COLOR<br>ARSENAZO III AA |
| Linearity | 20 mg/dl | |
| Expected values | Serum: 8.5-10.5 mg/dl<br>Urine: 60-200 mg/24hr | |
| Within-run<br>precision | Normal Level Serum:<br>CV = 1.28% | Normal Level Serum:<br>CV = 1.93% |
| | High Level Serum:<br>CV = 1.30% | High Level Serum:<br>CV = 0.88% |
| | Normal Level Urine<br>CV = 1.06% | Normal Level Urine<br>CV = 2.57% |
| | High Level Urine<br>CV = 0.68% | High Level Urine<br>CV = 1.79% |
| Run-to-run<br>precision | Normal Level Serum:<br>CV = 1.74% | Normal Level Serum:<br>CV = 1.74% |
| | High Level Serum:<br>CV = 1.70% | High Level Serum:<br>CV = 1.29% |
| | Normal Level Urine<br>CV = 2.50% | Normal Level Urine<br>CV = 2.44% |
| | High Level Urine<br>CV = 1.34% | High Level Urine<br>CV = 2.62% |

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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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is an emblem that resembles a stylized caduceus, with three horizontal lines above a wavy line. The emblem is black, and the background is white.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 1 0 2002

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

Re: k021334

> Trade/Device Name: Ca-Color Arsenazo III AA Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: August 1, 2002 Received: August 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 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/cdrlvdsmaldsmamain.html".

Sincerely yours,

Steven Putman

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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Page /

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Wiener lats. Arsena 70 III AA Ca -color.

Indications For Use:

The "Wiener lab. Ca-Color Arsenazo III AA" test stem = is quantitative in vitro diagnostic device intended to be "useds in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).

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

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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021334

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