(464 days)
Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma. Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a heparin assay device. It does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. Such information is usually found in the 510(k) summary or full submission, not in the FDA's decision letter.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.
The document primarily states that the device is substantially equivalent to a predicate device for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
ﺳﺔ
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 4 2006
HYPHEN BIOMED C/O Aniara Ola Anderson 6560 Gove Court Mason, Ohio 45040
Re: K050367
Trade/Device Name: BIOPHEN Heparin 3, BIOPHEN Heparin 6 Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF Dated: 12 May 2006 Received: 16 May 2006
Dear: Mr. Anderson
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., MD, PH.D 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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Section D. Statement of Indication for Use
510 (k) Number: 050367
Device Name: Biophen Heparin 3 Biophen Heparin 6
Indications for use:
Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma.
Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050367
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§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).