(111 days)
CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor V deficiencies in in vitro clot-based factor V assays using the one stage prothrombin time.
CryoCheck Factor V Deficient Plasma is human plasma deficient in the factor V coagulation protein while having all other coagulation factors within normal limits.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor V Deficient Plasma." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
However, the document does not contain any information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, or detailed performance metrics of the device as requested in your prompt. It is a regulatory approval letter, not a detailed technical or clinical study report.
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).