(14 days)
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.
Not Found
The retrieved document is a 510(k) premarket notification letter from the FDA regarding the Olympus Unsaturated Iron Binding Capacity device. This type of document does not typically contain the detailed technical study information requested, such as specific acceptance criteria, performance data, sample sizes for test and training sets, ground truth establishment, or details about expert involvement and adjudication.
The letter primarily focuses on:
- Confirming the review of the premarket notification.
- Determining substantial equivalence to a predicate device.
- Stating the device's regulation number, regulation name, and regulatory class.
- Specifying the "Indications for Use" for the device, which is to measure iron-binding capacity in serum and plasma for the diagnosis and treatment of anemia.
Therefore, I cannot extract the requested information from the provided text.
To answer your questions, one would need access to the actual 510(k) submission document or supporting studies that detail the device's performance validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
0055
§ 862.1415 Iron-binding capacity test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.