# K132130: Reagent, Russel Viper Venom - LA Screen

- Pathway: 510(k) (Special)
- Applicant: Dsrv, Inc.
- Decided: Jan 10, 2014 after 184 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
IFU Frozen Format LA Screen Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRWT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anicoagulants. This product is for in-vitmo diagnostic use only.

Source page: https://510kreport.com/device/K132130
Methodology: https://510kreport.com/methodology