(23 days)
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.
Olympus Ferritin Reagent
This document is a 510(k) premarket notification approval letter for the Olympus Ferritin Reagent. It does not contain information about acceptance criteria or a study proving that a device (in the sense of a diagnostic algorithm or imaging system) meets acceptance criteria.
The document discusses a reagent used in a laboratory test for ferritin concentrations. The FDA's determination is based on the substantial equivalence of this reagent to a legally marketed predicate device, not on specific performance criteria demonstrated by a clinical study of an AI-powered device or imaging system.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in the provided 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 866.5340 Ferritin immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).