(169 days)
IL Hemosil. von Willebrand Activity is an in vitro diagnostic automated immunolurbidometric assay for the quantitative determination of von Willebrand activity in human citrated plasma on IL Coagulation Systems.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "HemosIL von Willebrand Activity." This document is a regulatory approval letter and indications for use, not a study report or clinical trial summary. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.
The document indicates that the device is an in vitro diagnostic automated immunoturbidometric assay for the quantitative determination of von Willebrand activity in human citrated plasma. However, it does not provide any specific performance metrics, acceptance criteria, or details of a study that proves the device meets such criteria.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical performance data, which is not present in this regulatory letter.
§ 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).