# K132076: Reagent, Russel Viper Venom - LA Confirm

- Pathway: 510(k) (Special)
- Applicant: Dsrv, Inc.
- Decided: Jan 10, 2014 after 191 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
Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anicoagulants (LA) in one-stage clotting tests. Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent far the specific correction of Lupus Anticoagulants. This product is for in-viro diagnostic use only.

Source page: https://510kreport.com/device/K132076
Methodology: https://510kreport.com/methodology