# K990302: IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to Acl Futura)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 8, 1999 after 66 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: 1 generation back to K922156 (1993). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922156: Lucor Confirmatory Reagent, Gradipore, Ltd. (1993) Summary page 1.
- K922326: Lupo-Test Regeant, Graoipore, Ltd. (1993) Summary page 1.

## Most influential descendants
- K050221: Hemosil Silica Clotting Time (2005), 2 descendants of its own
- K160445: HemosIL Silica Clotting Time (2016), 1 descendant of its own
- K110031: Hemosil Drvvt Screen & Hemosil Drvvt Confirm (2011), 1 descendant of its own
- K061805: Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm (2006), 1 descendant of its own
- K253957: HemosIL Silica Clotting Time (2026), 0 descendants of its own

## Indications for use
IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. These tests are indicated for use with patients who have prolonged APTT test of undetermined origin. This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

Source page: https://510kreport.com/device/K990302
Methodology: https://510kreport.com/methodology