(168 days)
The Dimertest Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.
Not Found
The provided text describes a 510(k) clearance for the Dimertest Latex Assay but does not contain any information regarding specific acceptance criteria, study details, or performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the regulatory clearance of the device as substantially equivalent to a predicate device.
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).