(106 days)
CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clotbased factor VIII assays using the activated partial thromboplastin time.
CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits.
The provided text is a 510(k) clearance letter from the FDA for a device called "CryoCheck Factor VIII Deficient Plasma." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device.
The letter is a regulatory approval for an in vitro diagnostic product, not a software device, and primarily states that the device is substantially equivalent to existing devices. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, or AI/ML specific metrics.
To provide the requested information, a different type of document, such as a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML device, would be necessary.
§ 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).