HemosIL Silica Clotting Time

K253957 · Instrumentation Laboratory (IL) Co. · GFO · Jan 9, 2026 · Hematology

Device Facts

• Record ID: K253957
• Device Name: HemosIL Silica Clotting Time
• Applicant: Instrumentation Laboratory (IL) Co.
• Product Code: GFO · Hematology
• Decision Date: Jan 9, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

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.

Device Story

HemosIL Silica Clotting Time is an in vitro diagnostic reagent used for the detection of lupus anticoagulants. The device modification involves the removal of ACL Elite/Elite Pro instruments from the product labeling. The fundamental scientific technology remains unchanged. The device is intended for use by clinical laboratory professionals to assist in the diagnosis of coagulation disorders.

Clinical Evidence

No clinical data; bench testing only. The submission is a Special 510(k) for labeling changes (removal of instrument claims) and does not require new performance data.

Technological Characteristics

In vitro diagnostic reagent for coagulation testing. The modification is strictly a labeling change removing specific instrument compatibility. No changes to reagent composition, sensing principle, or physical characteristics.

Indications for Use

Indicated for the detection of Lupus Anticoagulants in human citrated plasma samples.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• HemosIL Silica Clotting Time (K253957)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K253957

B Applicant

Instrumentation Laboratory (IL) Co.

C Proprietary and Established Names

HemosIL Silica Clotting Time

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GFO | II | 21 CFR 864.7925 | Hematology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

- This change was to remove the ACL Elite/Elite Pro instruments from the HemosIL Silica Clotting Time Labeling.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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