# K083878: Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Jun 25, 2010 after 543 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: 3 generations back to K922156 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061805: Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm, Diagnostica Stago, Inc. (2006) Summary page 1.
- K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma, American Diagnostica, Inc. (1994) Summary page 1.

## Indications for use
PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma. LupoTek DetecTin VL, and CorrecTin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.

Source page: https://510kreport.com/device/K083878
Methodology: https://510kreport.com/methodology