# K061805: Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Dec 6, 2006 after 162 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
Longest line of descent: 2 generations back to K922156 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990302: IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to Acl Futura), Instrumentation Laboratory CO (1999) Summary page 1.

## Most influential descendants
- K083878: Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA (2010), 0 descendants of its own

## Indications for use
The STA®-Staclot®dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.

Source page: https://510kreport.com/device/K061805
Methodology: https://510kreport.com/methodology