OLYMPUS FERRITIN REAGENT

K030124 · Olympus America, Inc. · DBF · Feb 6, 2003 · Immunology

Device Facts

• Record ID: K030124
• Device Name: OLYMPUS FERRITIN REAGENT
• Applicant: Olympus America, Inc.
• Product Code: DBF · Immunology
• Decision Date: Feb 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

Reagent for the determination of ferritin concentrations in human serum using the Olympus family of clinical chemistry analyzers. Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bonemarrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Device Story

Olympus Ferritin Reagent is an in vitro diagnostic reagent used on Olympus clinical chemistry analyzers to measure ferritin concentrations in human serum. The device functions as an immunological test system to quantify ferritin, which serves as a clinical indicator of body iron stores. It is intended for use by laboratory professionals in clinical settings. By providing quantitative measurements of serum ferritin, the device assists clinicians in diagnosing conditions related to iron metabolism, specifically iron overload (hemochromatosis) and iron deficiency anemia. The output is a concentration value used by healthcare providers to assess patient iron status and guide clinical management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's performance as an immunological test system for ferritin determination.

Technological Characteristics

Immunological test system for ferritin; reagent-based assay designed for use on Olympus clinical chemistry analyzers. Class II device (21 CFR 866.5340).

Indications for Use

Indicated for the determination of ferritin concentrations in human serum to aid in the diagnosis of iron metabolism disorders, including hemochromatosis and iron deficiency anemia, in patients requiring assessment of body iron stores.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 0 6 2003

Mr. Michael Campbell Manager, RA/OA Olympus America Inc. 3131 West Royal Lane Irving, TX 75063-3104

Re: k030124

> Trade/Device Name: Olympus Ferritin Reagent Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF Dated: January 13, 2003 Received: January 14, 2003

Dear Mr. Campbell:

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).

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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.

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). 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 vours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K030124

Device Name:

Olympus Ferritin Reagent

Indications for Use:

Reagent for the determination of ferritin concentrations in human serum using the Olympus family of clinical chemistry analyzers.

Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bonemarrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Hfleures los J. Bautista

(Division Sign-Off)/
Division of Clinical Laboratory 24
510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (per 21 CFR 801.109) (Optional Format 1-2-96)