RDI HSFERRITIN KIT

K053211 · Reference Diagnostics, Inc. · DBF · Mar 13, 2006 · Immunology

Device Facts

• Record ID: K053211
• Device Name: RDI HSFERRITIN KIT
• Applicant: Reference Diagnostics, Inc.
• Product Code: DBF · Immunology
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The RDI Ferritin kit is for quantitative measurement of ferritin in human serum or plasma. Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

Device Story

RDI Ferritin is an immunoturbidimetric assay for quantitative measurement of ferritin in human serum or plasma. The device utilizes anti-ferritin antibodies attached to latex microparticles in a glycine buffer (pH 8.3). Upon contact with patient serum/plasma, an antigen-antibody reaction occurs, causing latex microparticle agglutination. The device measures this agglutination turbidimetrically via absorbance change at 600 nm on a Hitachi 911 analyzer. The magnitude of absorbance change is proportional to ferritin concentration. A standard curve, generated using known ferritin concentrations, allows calculation of patient values. The assay is intended for use in clinical laboratory settings to assist in assessing iron stores and evaluating iron deficiency anemia and hemochromatosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Turbidimetric immunoassay; utilizes latex microparticles coated with anti-ferritin antibodies in glycine buffer (pH 8.3). Detection via absorbance change at 600 nm. Designed for use on Hitachi 911 analyzer. Calibrators are liquid-form, traceable to WHO 3rd International Standard for Ferritin (94/572).

Indications for Use

Indicated for quantitative measurement of ferritin in human serum or plasma to assess iron stores and evaluate iron deficiency anemia and hemochromatosis.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

MAR 1 3 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730

Re: k053211

> Trade/Device Name: RDI Ferritin Kit Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: February 23, 2006 Received: February 24, 2006

Dear Dr. Lawlor:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment B.

## Indications for Use

510(k) Number (if known): K053211

Device Name: RDI Ferritin Kit

Indications For Use:

For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.

Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

Prescription Use
(Per 21 CFR 801.109)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

J. Rlove for m. Chen
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sailty

KO52211 . 510(k)_

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