# K110031: Hemosil Drvvt Screen & Hemosil Drvvt Confirm

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 24, 2011 after 231 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 2.

## Most influential descendants
- K113211: Hemosil LA Positive Control & Hemosil LA Negative Control (2012), 0 descendants of its own

## Indications for use
The HemosiL dRVVT Screen and HemosL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP Family. The HemoslL dRVVT Screen and Hemoslt dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosiL dRVVT Screen and HemosL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

Source page: https://510kreport.com/device/K110031
Methodology: https://510kreport.com/methodology