OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

K041793 · Olympus America, Inc. · JMO · Jul 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041793
• Device Name: OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
• Applicant: Olympus America, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

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

Device Story

The Olympus Unsaturated Iron Binding Capacity test system is an in vitro diagnostic device used to measure iron-binding capacity in serum and plasma samples. It is intended for use by healthcare professionals in clinical laboratory settings to assist in the diagnosis and treatment of anemia. The device functions as a chemical test system; it provides quantitative results that clinicians use to assess iron status and guide therapeutic decisions for patients suspected of having anemia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reagent R2a modified from powder to liquid state; linearity range 400-450 µg/dL.

Indications for Use

Indicated for the measurement of iron-binding capacity in serum and plasma for the diagnosis and treatment of anemia in patients.

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.

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract lines forming the body and head.

Public Health Service

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

JUL 1 6 2004

Ms. Bev Harding RA Analyst Olympus America Inc. 3131 West Royal Lane Irving, Texas 75063-3104

Re: k041793

Trade/Device Name: Olympus Unsaturated Iron Binding Capacity Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JMO Dated: June 30, 2004 Received: July 2, 2004

Dear Ms. Harding:

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). 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/dsma/dsmamain.html.

Sincerely yours,

Jann M. Cooper, U.S., D.V.M.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Olympus Unsaturated Iron Binding Capacity Premarket Notification

## Indications for Use

510(k) Number (if known):

K041793 Olympus Unsaturated Iron Binding Capacity.

Indications for Use:

Device Name:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K011793

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