WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002

K013652 · Wiener Laboratories Saic · CIC · Dec 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013652
• Device Name: WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
• Applicant: Wiener Laboratories Saic
• Product Code: CIC · Clinical Chemistry
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

The "Wiener lab. Ca-Color 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

In vitro diagnostic test system for quantitative calcium measurement in human serum, heparinized plasma, and urine. Principle: Calcium reacts with o-Cresolphtalein complexone (o-CPC) at pH 10.8 to form a purple complex; 8-hydroxyquinoline added to eliminate magnesium interference. Photocolorimetric measurement at 560-590 nm. Used in clinical laboratories; operated by technicians/clinicians. Manual or automated system compatibility. Output: Calcium concentration (mg/dL). Clinical utility: Aids diagnosis/treatment of parathyroid, bone, and renal diseases, and tetany.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (within-run and run-to-run CVs) for serum and urine samples. Within-run precision: Normal serum CV 1.28%, High serum CV 1.30%, Normal urine CV 1.06%, High urine CV 0.68%. Run-to-run precision: Normal serum CV 1.74%, High serum CV 1.70%, Normal urine CV 2.50%, High urine CV 1.34%. Linearity established up to 20 mg/dL.

Technological Characteristics

Photocolorimetric assay. Reagents: o-CPC, 8-hydroxyquinoline, 2-Amino-2-Methyl-1-Propanol. Wavelength: 560-590 nm. Operating temperature: Room temperature to 37°C. Compatible with manual and automated clinical chemistry analyzers. Storage: Room temperature.

Indications for Use

Indicated for quantitative determination of calcium in human serum, heparinized plasma, and urine. Used in 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

• POINTE CALCIUM REAGENT SET (Cat. Nº C7503-120)
• DMA CALCIUM test system (Cat. Nº 1250)

Submission Summary (Full Text)

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DEC 21 2001

Image /page/0/Picture/2 description: The image is a black and white circular logo or seal. The text "Wiener lab." is at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is at the bottom. Inside the circle are the words "ISO 9001" and the logo for "TUV CERT".

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 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"

KO13652 " "The assigned 510(k) number is: __

According to the requirements of 21 CFR 862.1145, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Lab Group 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Contact person: Viviana Cétola Date Prepared: August 28, 2001

Proprietary name: WIENER LAB. CA-COLOR AA 6-2 Device Name Common name: Calcium test system. Classification name: Cresolphthalein Complexone, Calcium Device Class II

We claim substantial equivalence to the currently marketed 6-3 Predicate POINTE CALCIUM REAGENT SET (Cat. Nº C7503-120) for Device the serum / plasma application and DMA CALCIUM test system (Cat. Nº 1250) for the urine application..

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Calcium reacts with o-Cresolphtalein complexone (o-CPC) at 6-4 Device pH 10.8, yielding a purple colored complex, which is Description photocolorimetrically measured at 570 nm. magnesium 8-hydroxyquinoline is added to remove interference.

The WIENER LAB. CA-COLOR AA test system is a 6-5 Intended Use 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 AA test system is substantially 6-6 Equivalencies equivalent to other products in commercial distribution and Differences intended for similar use. Most notably it is substantially equivalent to the currently marketed POINTE CALCIUM REAGENT SET for the serum / plasma application and DMA CALCIUM test system for the urine application.

> The following table illustrates the similarities and differences between the WIENER LAB. CA-COLOR AA test system and the currently marketed POINTE CALCIUM REAGENT SET.

| | POINTE<br>Test System | WIENER LAB. Test<br>System |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative<br>determination of<br>calcium in human<br>serum and heparinized<br>plasma. | Quantitative<br>determination of<br>calcium in human<br>serum, heparinized<br>plasma and urine. |
| Continued on next page | | |
| | POINTE<br>Test System | WIENER LAB. Test<br>System |
| Test principle | Calcium reacts with o-Cresolphtalein complexone<br>(o-CPC) at pH 10.8, yielding a purple colored<br>complex, which is photocolorimetrically<br>measured at 570 nm.<br>8-hydroxyquinoline is added to remove<br>magnesium interference. | |
| Essential<br>Components | o-CPC<br>8-hydroxyquinoline | |
| Reagents | R1: o-CPC /<br>8-hydroxyquinoline<br>R2: 2-Amino-2-Methyl-<br>1-Propanol /<br>Potassium Cyanide | R1: o-CPC /<br>8-hydroxyquinoline<br>R2: 2-Amino-2-Methyl-<br>1-Propanol |
| Reagent Storage | Under refrigeration (2-<br>8°C) | Room temperature |
| Reagent<br>Deterioration | Turbid reagent | Reagent Blank > 0.400<br>O.D. |
| Preparation of<br>Working Reagent | Mixture of R1 and R2<br>(1:1) | Mixture of R1 and R2<br>(1:1) or they can be<br>used separately. |
| Working Reagent<br>Stability | Stable 2 weeks at 2-<br>10°C and 1 week at<br>room temperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with diluted<br>hydrochloric acid and rinsed with distilled water. | |
| Working<br>Temperatures | Room temperature | Room temperature -<br>37°C |
| Wavelength of<br>reading. | 570 nm | 560 - 590 nm |
| Continued on next page | | |
| | POINTE<br>Test System | WIENER LAB. Test<br>System |
| Linearity | 20 mg/dl | |
| Expected values | Serum<br>8.5 - 10.5 mg/dl<br>Higher values in<br>children falling to<br>normal with aging. | Serum<br>8.5-10.5 mg/dl<br>Urine<br>60-200 mg/24hr |
| Within-run<br>precision | Normal Serum:<br>CV = 1.5%<br>Abnormal Serum:<br>CV = 1.0% | Normal Level Serum:<br>CV = 1.28%<br>High Level Serum:<br>CV = 1.30%<br>Normal Level Urine<br>CV = 1.06%<br>High Level Urine<br>CV = 0.68% |
| Run-to-run<br>precision | Normal Serum:<br>CV = 1.4%<br>Abnormal Serum:<br>CV = 2.1% | Normal Level Serum:<br>CV = 1.74%<br>High Level Serum:<br>CV = 1.70%<br>Normal Level Urine<br>CV = 2.50%<br>High Level Urine<br>CV = 1.34% |
| Continued on next page | | |

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Sale

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The following table illustrates the similarities and differences The following table fillustral critical CineTiCA AA test between the virently marketed DMA CALCIUM test system.

| | DMA<br>Test System | WIENER LAB. Test<br>System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative<br>determination of<br>calcium in human<br>serum and urine. | Quantitative<br>determination of<br>calcium in human<br>serum, heparinized<br>plasma and urine. |
| 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. | 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. |
| Essential<br>Components | o-CPC | o-CPC<br>8-hydroxyquinoline |
| Reagents | R1: o-CPC /<br>surfactant<br>R2: Diethylamine /<br>Potassium Cyanide | R1: o-CPC /<br>8-hydroxyquinoline<br>R2: 2-Amino-2-Methyl-<br>1-Propanol |
| Reagent Storage | Room temperature | |
| Continued on next page | | |
| | DMA<br>Test System | WIENER LAB. Test<br>System |
| Reagent<br>Deterioration | R1 darkened or with<br>precipitate<br>R2 turbid or colored<br>Reagent Blank > 0.500<br>O.D. | Reagent Blank > 0.400<br>O.D. |
| Preparation of<br>Working Reagent | Mixture of R1 and R2 (1:1) or they can be used<br>separately. | |
| Working Reagent<br>Stability | Stable 3 days at room<br>temperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with diluted<br>hydrochloric acid and rinsed with distilled water. | |
| Working<br>Temperatures | 30°C - 37°C | Room temperature -<br>37°C |
| Wavelength of<br>reading. | 550 - 585 nm | 560 - 590 nm |
| Linearity | 15 mg/dl | 20 mg/dl |
| Expected values | Serum<br>8.5 - 11.0 mg/dl<br>Urine<br>100-300 mg/24hr | Serum<br>8.5-10.5 mg/dl<br>Urine<br>60-200 mg/24hr |
| Within-run<br>precision | Normal Serum:<br>CV = 1.98%<br>Abnormal Serum:<br>CV = 1.40% | Normal Level Serum:<br>CV = 1.28%<br>High Level Serum:<br>CV = 1.30%<br>Normal Level Urine<br>CV = 1.06%<br>High Level Urine<br>CV = 0.68% |
| | DMA<br>Test System | WIENER LAB. Test<br>System |
| Run-to-run<br>precision | Normal Serum:<br>CV = 1.93% | Normal Level Serum:<br>CV = 1.74% |
| | Abnormal Serum:<br>CV = 2.40% | High Level Serum:<br>CV = 1.70% |
| | | Normal Level Urine<br>CV = 2.50%<br>High Level Urine<br>CV = 1.34% |

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Based on the data above mentioned, we believe that the 6-7 Conclusion extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with outstretched wings, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the circumference of the circle. The logo is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

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

Re: k013652

Trade/Device Name: Weiner Lab. CA-COLOR AA Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC Dated: October 15, 2001 Received: November 6, 2001

Dear Dr. Cetola:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowed your 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 I ou may a 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 may or subject to been 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 or any I cather bather 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 Of It Fart 6777 accems (21 (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 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, (Jease 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 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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CDkil Over

Page _ of _

| 510(k) Number (if known): | K013652 |
|---------------------------|-------------|
| Device Name: | Wiener lab. |
| | CA-COLOR AA |

10013652

Indications For Use:

The "Wiener lab. Ca-Color AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination diagnootio actionwan sera, heparinized plasmas and urine on both or ourolum in hamated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone the diagnoois and trenal diseases and tetany (intermittent muscular contractions or spasms)

| contractions of spasms). | |
|-----------------------------------------|---------|
| K013652 - Manuel C.Hurt for Jean Cooper | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K013652 |

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

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)

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