(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.
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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.
§ 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).