(64 days)
Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.
Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.
Not Found
I apologize, but the provided text from the FDA 510(k) approval letter for the Bioclot® aPC Sensitivity Kit does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
The document is a letter indicating substantial equivalence to a predicate device, allowing the kit to be marketed. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test or training sets, data provenance, or ground truth establishment.
- Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
- Results from standalone algorithm performance studies.
Therefore, I cannot fulfill your request based on the provided input.
§ 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).