# K050221: Hemosil Silica Clotting Time

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 30, 2005 after 58 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 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
- K160445: HemosIL Silica Clotting Time (2016), 1 descendant of its own
- K253957: HemosIL Silica Clotting Time (2026), 0 descendants of its own

## Indications for use
HemosiL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized tD phospholipid dependent antibodies.

Source page: https://510kreport.com/device/K050221
Methodology: https://510kreport.com/methodology