WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003

K013097 · Wiener Laboratories Saic · JIY · Nov 13, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013097
• Device Name: WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
• Applicant: Wiener Laboratories Saic
• Product Code: JIY · Clinical Chemistry
• Decision Date: Nov 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

The "Wiener lab. Fer-Color AA" iron test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of iron (non-heme) in human serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Device Story

FER-COLOR AA is an in vitro diagnostic test system for quantitative iron determination in human serum and plasma. Principle: End-point photometric method. Serum iron is released from transferrin using pH 4.5 acetate buffer and reduced to ferrous form by ascorbic acid; ferrous iron reacts with ferrozine to form a colored complex measured at 540-580 nm. Used in clinical laboratories by trained personnel. Output is a quantitative iron concentration value (µg/dl). Results assist clinicians in diagnosing and monitoring iron deficiency anemia, hemochromatosis, and chronic renal disease.

Clinical Evidence

Bench testing only. Performance data includes linearity (up to 1000 µg/dl), minimum detection limit (6.1 µg/dl), and precision studies. Intra-assay precision reported as CV 1.32% (normal) and 0.54% (abnormal); inter-assay precision reported as CV 1.75% (normal) and 1.25% (abnormal). No clinical prospective or retrospective studies provided.

Technological Characteristics

Photometric iron (non-heme) test system. Reagents: Acetate buffer, ascorbic acid (reducing agent), and ferrozine (color reagent). Principle: End-point colorimetric reaction measured at 540-580 nm. Form factor: Liquid reagents for manual or automated clinical chemistry analyzer use. No electronic components or software algorithms.

Indications for Use

Indicated for quantitative determination of iron in human serum and plasma for patients suspected of iron deficiency anemia, hemochromatosis, or chronic renal disease.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Predicate Devices

• RANDOX IRON test system

Submission Summary (Full Text)

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FER-COLOR AA Wiener lab.

NOV 1 3 2001

Image /page/0/Picture/2 description: The image is a circular seal with the text "Wiener lab." at the top. Inside the circle, there is a logo with the letters "ISO 9001" above the letters "TUV CERT". The text "SISTEMA DE CALIDAD CERTIFICADO" is written along the bottom of the circle.

Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized letter 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 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"

"The assigned 510(k) number is: y

Introduction

According to the requirements of 21 CFR 862.1410, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.

6-1 Submitter Name, Address, Contact

Wiener Laboratorios S.A.I.C. Riobamba 2944 2000 - Rosario - Argentina Contact person: Viviana Cétola Date Prepared: June 20, 2001

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| 6-2 Device Name | Proprietary name: WIENER LAB FER-COLOR AA<br>Common name: Photometric method for Iron determination.<br>Classification name: Photometric method, iron (non-heme).<br>Device Class I<br>Product Code: JIY |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-3 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>RANDOX IRON test system. |
| 6-4 Device<br>Description | End point method. |
| | Serum iron is released from its specific carrier protein<br>(transferrin) in a pH 4.5 acetate buffer, and in the presence of a<br>reducing agent (ascorbic acid). Then it reacts with the color<br>reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine)<br>producing a colored complex measured at 570 nm. |
| 6-5 Intended Use | FER-COLOR AA test system is intended to be used in the<br>quantitative determination of iron in human serum and plasma.<br>Iron (non-heme) measurements are used in the diagnosis and<br>treatment of diseases such as iron deficiency anemia,<br>hemochromatosis (a disease associated with widespread<br>deposit in the tissues of two iron-containing pigments,<br>hemosiderin and hemofuscin, and characterized by<br>pigmentation of the skin), and chronic renal disease. |
| 6-6 Equivalencies<br>and Differences | WIENER LAB. FER-COLOR AA test system is substantially<br>equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the<br>currently marketed RANDOX IRON test system. |
| | The following table illustrates the similarities and differences<br>between WIENER LAB. FER-COLOR AA test system and the<br>currently marketed RANDOX IRON test system. |

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| | RANDOX Test<br>System | WIENER LAB. Test<br>System |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended use | Quantitative determination of iron in human<br>serum and plasma | |
| Test principle | End point method.<br>Serum iron is released from its specific carrier<br>protein (transferrin) in a pH 4.5 acetate buffer.<br>The ferric iron is converted to the ferrous form<br>by the action of a reducing agent (ascorbic<br>acid). Then it reacts with the color reagent,<br>pyridyl bis-phenyl triazine sulfonate (ferrozine)<br>producing a colored complex measured at<br>540/580 nm. | |
| Essential<br>Components | Buffer acetate - Ascorbic acid - Ferrozine | |
| Reagents | R1: Buffer acetate<br>R2: Ascorbic acid -<br>Ferrozine | R1: Ferrozine<br>R2: Buffer acetate<br>R3: Ascorbic acid<br>(reductor) |
| Preparation of<br>Working Reagent | R1 and R2 ready to<br>use | Preparation of Buffer/<br>Reductor |
| Instability or<br>deterioration of<br>reagents | Not specified | Change in Blank<br>and/or Standard<br>Absorbances |
| Sample | Serum and plasma. | |
| Working<br>Temperature Range | 25 - 37°C | |
| Stability of final<br>color | Not specified | 5 to 60 minutes |
| | RANDOX Test<br>System | WIENER LAB. Test<br>System |
| Wavelength of<br>reading. | 570 nm | 540 - 580 nm |
| Linearity | 1000 µg/dl | |
| Minimum detection<br>limit | Not specified | 6.1 µg/dl |
| Expected values | Male<br>10.6 – 28.3 µmol/l<br>(59-158 µg/dl)<br>Female<br>6.6 – 26.0 µmol/l<br>(37-145 µg/dl) | 60 -160 µg/dl |
| Intra-assay<br>precision | Level 1:<br>CV = 2.93%<br>Level 2:<br>CV = 2.29% | Normal Serum Control:<br>CV = 1.32 %<br>Abnormal Serum<br>Control:<br>CV = 0.54% |
| Inter-assay<br>precision | Not specified | Normal Serum Control:<br>CV =1.75%<br>Abnormal Serum<br>Control:<br>CV = 1.25% |

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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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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 eagle symbol, represented by three curved lines that form the shape of a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 1 3 2001

k013097 Re: Trade/Device Name: Fer-Color AA Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I, reserved Product Code: JIY Dated: July 26, 2001

Received: September 17, 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 noutheation. The I Dr 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 IT you desire spoolite as in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 dditionally, for questions on the promotion and advertising of your device, [phone]. I radiation f 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 mountacturers 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 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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CDRH ODE

K013097

## NOV 1 3 2001

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Wiener lab For-Color An

Indications For Use:

The "Wiener lab. Fer-Color AA" iron test system is a quantitative in The Wiener Tab. I CF-Ooler 70 t Tren coure iron (non-heme) in serum vitro diagnostic device intonation to urements are used in the diagnosis treatment of diseases such as iron deficiency anemia, and hemochromatosis (a disease associated with widespread deposit in the nemochromatosis (a discuss aporomants, hemosiderin and hemofuscin,
tissues of two iron-containing pigments, hemosiderin, and obronic repal tissues of two frontoning pigmentation of the skin), and chronic renal disease.

Division of Clinical La Gratory Levices

(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDBED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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0 M (Division Sign-Off)

510(k) Number_K

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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