(139 days)
CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.
CryoCheck APC Resistant Plasma
The provided text is a 510(k) clearance letter from the FDA for a device called "CRYOV CHECK™ APC RESISTANT PLASMA." It confirms that the device is substantially equivalent to a predicate device and can be marketed.
However, the document does not contain any information about acceptance criteria for device performance, nor does it detail any study that proves the device meets specific performance criteria. It is a regulatory approval document, not a scientific study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The requested information (sample size, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth, training set size, training set ground truth) is not present in this regulatory letter.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.