HemosIL Factor V Leiden (APC Resistance V)

HemosIL Factor V Leiden (APC Resistance V) is an in vitro diagnostic test that detects resistance to activated Protein C caused by the Factor V Leiden mutation in blood plasma. It is used to identify individuals at risk for thrombosis and can be performed on samples from untreated patients as well as those receiving oral anticoagulant or heparin therapy.

The device uses an APTT-based (activated partial thromboplastin time) assay methodology with Factor V Reagent Plasma normalization to increase sensitivity and specificity for the Factor V:Q506 mutation. The kit composition includes APTT reagent, Factor V Reagent Plasma, APC/calcium chloride, calcium chloride, and two levels of control plasma. The only differences from the predicate are modified on-board stability claims: 24 hours at 15°C for ACL TOP platforms (reduced from 3 days) and 4 hours at 15-25°C for ACL Elite/Elite Pro (newly added claim).

CLSI EP25, 2nd Edition was used as the well-established method to evaluate the on-board stability changes.

The device remains substantially equivalent because it has identical intended use, methodology, composition, and instrumentation platforms as the predicate (K963111). The only changes are to labeled on-board stability claims, which were evaluated using an FDA-recognized standard and do not affect the device's fundamental operating principle or safety and effectiveness. No changes were made to indications for use, formulation, or operating principle.