WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002

K013102 · Wiener Laboratories Saic · JMO · Nov 13, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013102
• Device Name: WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
• Applicant: Wiener Laboratories Saic
• Product Code: JMO · Clinical Chemistry
• Decision Date: Nov 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

Wiener lab. Fer-Color Transferrina is used for the quantitative determination of Total Iron binding capacity in human serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Device Story

The Wiener lab. Fer-Color Transferrina is an in vitro diagnostic test system used to determine Total Iron Binding Capacity (TIBC) in human serum or plasma. The device operates via an end-point photometric method. First, excess Fe(III) is added to the sample to saturate transferrin at a pH > 7.2. Unbound Fe(III) is removed via coprecipitation with magnesium carbonate followed by centrifugation. The iron bound to transferrin in the supernatant is then released in a pH 4.5 acetate buffer containing ascorbic acid as a reducing agent. The released iron reacts with the color reagent ferrozine (pyridyl bis-phenyl triazine sulfonate) to form a colored complex, which is measured spectrophotometrically at 570 nm. The test is performed in a clinical laboratory setting by trained personnel. Results are used by clinicians to assess iron status and manage anemia.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and comparison of the test principle and methodology to the predicate device.

Technological Characteristics

Photometric colorimetric assay. Reagents include iron solution and magnesium carbonate. Detection utilizes ferrozine reagent forming a complex measured at 570 nm. The process involves pH-controlled iron release (pH 4.5 acetate buffer) and reduction (ascorbic acid). The device is a manual or automated photometric test system for clinical laboratory use.

Indications for Use

Indicated for the quantitative in vitro diagnostic measurement of iron-binding capacity in human serum or plasma to assist in the diagnosis and treatment of anemia.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system

Submission Summary (Full Text)

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NOV 1 3 2001

Image /page/0/Picture/2 description: The image is a black and white circular seal or logo. The text "Wiener lab." is at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is at the bottom. The seal also contains the text "ISO 9001" and the logo of "TÜV CERT" in the center. The seal appears to be a certification mark, possibly indicating that Wiener lab. meets the ISO 9001 quality management standards.

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." to the right. Below the company name is the text "Especialidades para Laboratorios Clinicos".

**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: | 01310 7-リア

Introduction

According to the requirements of 21 CFR 862.1415, 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 TRANSFERRINA<br>Common name: Photometric method for Total – Iron Binding<br>Capacity determination.<br>Classification name: Ferrozine (colorimetric) Iron Binding<br>Capacity<br>Device Class I<br>Product Code: JMO |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-3 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>RANDOX TOTAL-IRON BINDING CAPACITY / IRON test<br>system. |
| 6-4 Device<br>Description | End point method.<br>Transferrin or specific iron carrier protein is assayed through its<br>physiologic activity of binding Fe (III) (TIBC) at a pH higher than<br>7.2 in which transferrin is saturated in the presence of excess Fe<br>(III). The remaining unbound Fe (III) is totally removed by<br>coprecipitation with magnesium carbonate. After centrifugation,<br>iron in the supernatant is determined as follows: iron bound to<br>transferrin is released and colorimetrically measured according to<br>Fer-Color procedure.<br>Such measurement proceeds as follows: iron is released from its |

specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.

Wiener lab FER-COLOR TRANSFERRINA is used for the 6-5 Intended Use quantitative determination of Total Iron binding capacity in human serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

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WIENER LAB. FER-COLOR TRANSFERRINA test system is 6-6 Equivalencies WIENER END equivalent to other products in commercial and Differences distribution intended for similar use. Most notably it is distantially equivalent to the currently marketed RANDOX IRON test system.

> The following table illustrates the similarities and differences The Tollowing Lable Fifastials FER-COLOR TRANSFERRINA/ FER-COLOR AA test system and the currently marketed FER-COLOR TOTAL-IRON BINDING CAPACITY/IRON test system.

| | RANDOX Auxiliary<br>Reagents for TIBC | WIENER LAB.<br>Auxiliary Reagents<br>for TIBC |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended use | Quantitative determination of Total - Iron<br>Binding Capacity (TIBC) in human serum. | |
| Test Principle | An excess of iron is added to the sample to<br>saturate the transferrin. The unbound iron is<br>precipitated with magnesium carbonate. After<br>centrifugation the iron in the supernatant is<br>determined with ferrozine. | |
| Reagents for Iron<br>Binding capacity | R1 Iron Solution<br>R2 Magnesium Carbonate | |
| Expected values | 46.0 -69.5 µmol/l<br>(259 - 388 µg/dl) | 250 - 400 µg/dl |

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.

## 6 - 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 3 2001

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

k013102 Re:

Trade/Device Name: Fer-Color Transferrina Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I, reserved Product Code: JMO 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 wt have teviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the excreen. 976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, are occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free (110.) the device, subject to the general controls provisions of the Act. The I ou may, dicrorore, mains 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 If your device is elabilional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and the fi may or subject to back areas 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 r lease oc advisou that i Drimination that your device complies with other requirements of the Act that I Dr has intact and regulations administered by other Federal agencies. You must or any I vith 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 Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality by over of ovisions (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 notification. The I Dri Imania of succioin 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 (2) CFR Part 801 and 1 IT you desire specific advices from your astic devices), please contact the Office of Compliance at additionally 607.10 for m Prive craguestions on the promotion and advertising of your device, [phone]. Traditionally, 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 information on your responsibilities and er Assistance at its toll-free number [phone] or Manufactors International and Solass "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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CDRH ODE

KD13102

## NOV 1 3 2001

Page 1 of 1

| 510(k) Number (if known): | K013102 |
|---------------------------|------------------------|
| Device Name: | Wiener lab. |
| | Fer-Color Trausferrina |

## Indications For Use:

The "Wiener lab. Fer-Color Transferrina" iron-binding capacity test The "Wiener Tab. Fel-Color" Transformine "weae intended to measure
system is a quantitative in vitro diagnostics device intended to measure system is a quantitative in vitro unagnosia. Iron-binding capacity
iron-binding capacity in serum or plasma. Iron-binding capacity iron-binding "Capacity" in "Scrain" of "practice" (freatment of anemia.

Jean Cooper

(Division Sign-Off)
Division of Medical Laboratory I
510(k) number: K013102

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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RECEIVED

SE 17

FDA/CDRH/ODE

12 32 PM 01
Prescription Usc (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

C.H.

I

SK28