# K193556: Cryocheck Hex LA

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Oct 23, 2020 after 305 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923731 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923731: Staclot LA Test Kit, American Bioproducts Co. (1992) Summary page 4.

## Indications for use
Cryocheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. Cryocheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

Source page: https://510kreport.com/device/K193556
Methodology: https://510kreport.com/methodology