# K253957: HemosIL Silica Clotting Time

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory (IL) Co.
- Decided: Jan 9, 2026 after 30 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: 4 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)
- K160445: HemosIL Silica Clotting Time, Instrumentation Laboratory CO (2016) Summary page 5.

## 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 to phospholipid dependent antibodies.

Source page: https://510kreport.com/device/K253957
Methodology: https://510kreport.com/methodology