# K990579: Cryocheck LA Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Jul 23, 1999 after 150 days
- Product code: GIR (Reagent, Russel Viper Venom)
- Device class: 1
- Regulation: 21 CFR 864.8950
- 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
Cryov'Check™ LA Check™ dilute Russell’s Viper Venom Test (dRVVT) reagent is a low concentration phospholipid reagent intended for use as a screening test for the presence of lupus anticoagulants (LA). It may be used in conjunction with Cryov'Check™ LA Sure™ (a high concentration phospholipid confirmatory reagent) to establish a ratio (LA Check/LA Sure) useful in discriminating between LA positive and LA negative specimens.

Source page: https://510kreport.com/device/K990579
Methodology: https://510kreport.com/methodology