# K983898: Bioclot Apc Sensitivity

- Pathway: 510(k) (Traditional)
- Applicant: Biopool Intl., Inc.
- Decided: Jan 6, 1999 after 64 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay. Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.

Source page: https://510kreport.com/device/K983898
Methodology: https://510kreport.com/methodology