HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL are in vitro diagnostic assays for quantitative determination of fibrinogen in human citrated plasma using the Clauss method. They are used on IL Coagulation Systems to measure fibrinogen levels, which helps evaluate blood coagulation disorders, disseminated intravascular coagulation, liver disease, and other clinical conditions.

The devices use the same composition (lyophilized bovine thrombin with bovine albumin, calcium chloride, buffer and stabilizers), methodology (Clauss method), sample type (human citrated plasma), and instrumentation as the predicate. The only modification is removal of the frozen stability claim for reconstituted reagent; the new labeling states 'Do not freeze reconstituted reagent' instead of allowing 1-month stability at -20°C.

Not stated in this summary.

The submission qualifies as a Special 510(k) because it involves only a labeling change with no modifications to the device's operating principle, formulation, assay algorithm, or performance characteristics. Removing a frozen stability claim and adding a restriction against freezing does not introduce new safety or effectiveness concerns, as the same reagent composition and methodology remain unchanged. Since no new performance data are required to remove an existing stability claim, and the manufacturer is authorized to market the existing device, substantial equivalence is maintained to the predicate K073367.