WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001

K012326 · Wiener Laboratories Saic · JGJ · Nov 8, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012326
• Device Name: WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
• Applicant: Wiener Laboratories Saic
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Nov 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

The "Wiener lab. Mg-color AA" test system is a device intended to be used in the quantitative determination of magnesium in human serum, plasma and urine. Magnesium measurement are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Device Story

The Mg-Color AA is an in vitro diagnostic test system for measuring magnesium levels in human serum, plasma, and urine. The device utilizes a photometric method where magnesium reacts with xylidyl blue in an alkaline solution in the presence of EGTA (which complexes with calcium to ensure specificity). This reaction produces a purple complex; the intensity of the color is proportional to the magnesium concentration. The test is performed in a clinical laboratory setting by trained personnel. The output is a photometric measurement of color intensity, which is used by clinicians to assess magnesium status and guide the diagnosis and treatment of hypo- or hypermagnesemia.

Clinical Evidence

Bench testing only. Performance data includes linearity (up to 6.00 mg/dl), minimum detection limit (0.08 mg/dl), and precision studies. Intra-assay precision (CV) ranged from 1.5% to 2.0% for serum and 1.5% for urine. Inter-assay precision (CV) ranged from 1.9% to 3.3% for serum and 1.9% to 3.1% for urine. Comparison of expected values provided for serum, plasma, and urine.

Technological Characteristics

Photometric magnesium test system. Reagent contains buffer, EGTA, and xylidyl blue. Operates at 25-37°C with reading wavelength range of 510-600 nm. Single-point calibration. Manual or automated photometric analysis.

Indications for Use

Indicated for quantitative determination of magnesium in human serum, plasma, and urine to diagnose and treat hypomagnesemia and hypermagnesemia.

Regulatory Classification

Identification

A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Predicate Devices

• ROCHE MAGNESIUM test system (Cat. Nº 1489330)

Submission Summary (Full Text)

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## NOV 0 9 2001

Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the text "Wiener lab." at the top, "SISTEMA DE CALIDAD CERTIFICADO" around the bottom, and "ISO 9001" in the center. There is a logo above the text "ISO 9001" and "TUV CERT" below it.

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 bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clínicos" in a smaller font size.

**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: ______________________________________________________________________________________________________________________________________________

According to the requirements of 21 CFR 862.1495, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Lab Group 1) Submitter name, Riobamba 2944 address, contact 2000 - Rosario - Argentina

Contact person: Viviana Cétola

Date Prepared: March 20, 2001

Proprietary name: Mg-Color AA 2) Device name

Common name: Magnesium test system

Classification name: Photometric method, Magnesium as per 21 CFR Section 862.1495 Device Class I

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3) Predicate Device We claim substantial equivalence to the currently marketed ROCHE MAGNESIUM test system (Cat. Nº 1489330).

Magnesium, in the presence of EGTA, is coupled with xylidyl 4) Device blue in an alkaline solution. descriptions

> -- ► purple complex Mg + Xylidyl blue

EGTA in the reagent complexes with calcium, so that only magnesium react with the indicator. The intensity of purple complex color formed is proportional to the magnesium concentration and can be measured photometrically.

The Mg-COLOR AA reagent is intended to be used in the 5) Intended use quantitative determination of magnesium in human serum, plasma and urine. Magnesium measurement are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Wiener lab. Magnesium test system is substantially 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 ROCHE MAGNESIUM test system.

> The following table illustrates the similarities and differences between the Wiener lab. Magnesium test system and the currently market ROCHE MAGNESIUM test system.

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| | ROCHE Test System | WIENER LAB. Test<br>System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of magnesium in human<br>serum, plasma and urine. | |
| Test principle | Magnesium, in the presence of EGTA, is coupled<br>with xylidyl blue in an alkaline solution.<br>$Mg + Xylidyl blue \longrightarrow purple complex$<br>EGTA in the reagent complexes with calcium, so<br>that only magnesium react with the indicator. The<br>intensity of purple complex color formed is<br>proportional to the magnesium concentration and<br>can be measured photometrically. | |
| Essential<br>Components | Xylidyl blue - EGTA | |
| Reagents | R1: Buffer/EGTA<br>R2: Xylidyl Blue | R: Buffer/EGTA/Xylidyl<br>Blue |
| Reagent<br>handling | Ready to use | |
| Instability or<br>deterioration of<br>reagents | Not specified | Reagent decoloration or<br>decreased pH |
| Sample | Serum, heparinized plasma and urine | |
| Working<br>Temperature<br>Range | | 25 - 37°C |
| Stability of final<br>color | Not specified | 60 minutes |
| Wavelength<br>range of reading. | 505-600 nm | 510 -600 nm |
| | | Continued on next page |
| | ROCHE Test System | WIENER LAB. Test<br>System |
| Calibration | Single point | |
| Linearity | 4.86 mg/dl | 6.00 mg/dl |
| Minimum<br>detection limit | 0.07 mg/dl | 0.08 mg/dl |
| Expected values | Serum and plasma:<br>1.58-2.55 mg/dl | Serum and plasma:<br>1.9-2.5 mg/dl |
| | Urine:<br>60-210mg/24 hs | Urine:<br>50-150 mg/24 hs |
| | 4.10-13.80 mg/dl | 1-10 mg/dl |
| Intra-assay<br>precision | Normal Serum Control:<br>CV = 0.8% | Normal Serum Control:<br>CV = 2.0% |
| | Abnormal Serum Control:<br>CV = 0.7% | Abnormal Serum Control:<br>CV = 1.9% |
| | Human Urine 1<br>CV = 3.2% | Human Urine 1<br>CV = 1.5% |
| | Human Urine 2<br>CV = 0.6% | Human Urine 2<br>CV = 1.5% |
| Inter-assay<br>precision | Normal Serum Control:<br>CV = 1.6%<br>Abnormal Serum Control:<br>CV = 2.6%<br>Human Urine 1<br>CV = 6.3%<br>Human Urine 2<br>CV = 1.6% | Normal Serum Control:<br>CV = 2.6%<br>Abnormal Serum Control:<br>CV = 3.3%<br>Human Urine 1<br>CV = 3.1%<br>Human Urine 2<br>CV = 1.9% |

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Based on the data above mentioned, we believe that the 7) Conclusion Based on the data above none support substantial equivalence to extended claims commercial distribution intended for similar use

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Image /page/5/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures in profile facing right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 0 9 2001

Re: k012326

Trade/Device Name: Mg-color AA Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium test system Regulatory Class: Class I, reserved Product Code: JGJ Dated: October 1, 2001 Received: October 9, 2001

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/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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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NOV 0 9 2001

Page_Lof_1_

| 510(k) Number (if known): | K012326 |
|---------------------------|-------------|
| Device Name: | Wiener lab. |
| | Mg-coler AA |

Indications For Use:

The "Wiener lab. Mg-color AA" test system is a device intended to be used in The Vierler lab. Mg oolor 7 + << << reserver in human serum, plasma and the quantitative determination of magness and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Rute Chisler for Jean Corpu

(Division Sign-Off)
Division of Clinical Laboratory Devices
K012326

(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)

510(k) Number.

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

PROMOTION