(53 days)
The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.
Not Found
The provided text details an FDA 510(k) clearance for the K-ASSAY Fibrinogen device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document is a clearance letter from the FDA to Kamiya Biomedical Company, stating that their K-ASSAY Fibrinogen device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory class, product code, and marketing permissions. The "Indications for Use Statement" simply describes what the device is intended for (determining fibrinogen levels in disseminated intravascular coagulation and primary fibrinolysis for in vitro diagnostic use).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.