Instrumentation Laboratory (IL) Co. · Class II · Cleared Jan 9, 2026
| K-number | K253957 |
| Device name | HemosIL Silica Clotting Time |
| Applicant | Instrumentation Laboratory (IL) Co. |
| Product code | GFO |
| Device class | Class II |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 864.7925 |
HemosIL Silica Clotting Time is a reagent-based diagnostic test that detects Lupus Anticoagulants in human blood plasma using screening (SCT Screen) and confirmatory (SCT Confirm) reagents. The test works by measuring clotting time in the presence of silica and phospholipid-sensitized reagents on IL Coagulation Systems.
The device consists of SCT Screen (poor in phospholipid, sensitive to LA), SCT Confirm (higher phospholipid content to neutralize LA), and SCT CaCl2 (calcium chloride). It uses a clotting time methodology that directly activates the intrinsic coagulation pathway and is unaffected by factor VII deficiencies, warfarin treatment, or inhibitors, making it more specific than APTT or dilute PT tests.
CLSI Guideline H60 is cited regarding potential falsely prolonged clotting times in heparin-containing patient samples.
This submission qualifies as a Special 510(k) because the only change is removal of performance claims for the ACL Elite/Elite Pro instruments while maintaining all other characteristics identical to the predicate device (K160445). No new performance data were needed, and there are no changes to indications for use, operating principle, formulation, or other labeled performance claims.
View the full FDA submission: accessdata.fda.gov