HemosIL Factor V Leiden (APC Resistance V)

K260551 · Instrumentation Laboratory (IL) Co. · GGW · Mar 20, 2026 · Hematology

Device Facts

• Record ID: K260551
• Device Name: HemosIL Factor V Leiden (APC Resistance V)
• Applicant: Instrumentation Laboratory (IL) Co.
• Product Code: GGW · Hematology
• Decision Date: Mar 20, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Indications for Use

The HemosIL Factor V Leiden (APC Resistance V) is an in vitro diagnostic assay for the quantitative determination of Activated Protein C (APC) resistance in human citrated plasma on ACL systems.

Device Story

In vitro diagnostic assay; measures APC resistance in human citrated plasma; performed on ACL Elite/Elite Pro, ACL TOP Family, ACL TOP Family 50 Series, and ACL TOP Family 70 Series systems. Modification involves updating on-board stability claims: 4-hour claim for ACL Elite/Elite Pro; 24-hour claim for ACL TOP series. Device aids clinicians in assessing Factor V Leiden mutation status. Operates in clinical laboratory settings; processed by laboratory technicians. Output provides quantitative coagulation data used by physicians to evaluate thrombotic risk.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm impact of modified on-board stability claims.

Technological Characteristics

In vitro diagnostic reagent kit containing APTT reagent (purified phospholipids, colloidal silica), Factor V Reagent Plasma, APC/CaCl2, and CaCl2 in Tris buffer. Operates on automated coagulation analyzers (ACL TOP and ACL Elite families). Stability validated per CLSI EP25.

Indications for Use

Indicated for the quantitative determination of Activated Protein C (APC) resistance in human citrated plasma to aid in the assessment of Factor V Leiden mutation status.

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 Factor V Leiden (APC Resistance V) (K963111)

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

K260551

B Applicant

Instrumentation Laboratory (IL) Co.

C Proprietary and Established Names

HemosIL Factor V Leiden (APC Resistance V)

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GGW | Class II | 21 CFR 864.7925 - Partial Thromboplastin Time Tests | HE - 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 demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change includes:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Adding a 4-hour on-board stability claim to ACL Elite/Elite Pro (K060162).
- Reducing on-board stability claim from 72 hours to 24 hours on ACL TOP Family (K073377), ACL TOP Family 50 Series (K150877), ACL TOP Family 70 Series (K231031).

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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