(297 days)
The Rapid Genotyping Assay - CYP2C9 & VKORC1 is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity.
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The provided text is a 510(k) clearance letter from the FDA for the "Rapid Genotyping Assay - CYP2C9 & VKORC1." This document primarily grants marketing authorization and outlines the intended use of the device. It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document references a "Section 510(k) premarket notification," which is where such details would typically be found. This clearance letter is a summary of the FDA's decision, not the full submission itself.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).