HemosIL Liquid Anti-Xa

K213464 · Instrumentation Laboratory CO · KFF · Oct 4, 2022 · Hematology

Device Facts

• Record ID: K213464
• Device Name: HemosIL Liquid Anti-Xa
• Applicant: Instrumentation Laboratory CO
• Product Code: KFF · Hematology
• Decision Date: Oct 4, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Indications for Use

The HemosIL Liquid Anti-Xa is an automated, liquid, ready-to-use, chromogenic assay for the quantitative determination of heparin (unfractionated and low molecular weight) activity in human citrated plasma on the ACL TOP Family and ACL TOP Family 50 Series of instruments.

Device Story

HemosIL Liquid Anti-Xa is a chromogenic assay for quantitative heparin activity measurement in human citrated plasma; used on ACL TOP Family and ACL TOP Family 50 Series instruments. Modification extends on-board reagent stability to 4 days; removes claim for ACL Elite/Elite Pro instrument family. Assay utilizes chromogenic principle to measure anti-Xa activity; results used by clinicians to monitor heparin therapy. Device operates in clinical laboratory settings; performed by laboratory technicians. Output provides quantitative heparin activity levels to assist in therapeutic decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities performed to support the modification of on-board reagent stability claims and removal of instrument compatibility claims. No clinical data required for this modification.

Technological Characteristics

One-stage chromogenic assay; synthetic chromogenic substrate; Factor Xa inactivation principle. Reagents include dextran sulfate. Kinetic measurement at 405 nm. Automated processing on ACL TOP Family/ACL TOP Family 50 Series. Quantitative output. No changes to formulation or operating principle.

Indications for Use

Indicated for quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity in human citrated plasma for patients requiring heparin therapy monitoring.

Regulatory Classification

Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

Predicate Devices

• HemosIL Liquid Anti-Xa (K142636)

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

K213464

B Applicant

Instrumentation Laboratory Co.

C Proprietary and Established Names

HemosIL Liquid Anti-Xa

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| KFF | Class II | 21 CFR 864.7525 - Heparin Assay | HE - Hematology |
| QLU | Class II | 21 CFR 864.7295 - Heparin and direct oral factor Xa inhibitor drug test system | 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.
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.
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.

The changes include:

- Modification of on-board reagent stability claim for HemosIL Liquid Anti-Xa on the ACL TOP Family and ACL TOP Family 50 Series to four (4) days.
- Removal of claim for quantitative determination of unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) activity using HemosIL Liquid Anti-Xa on the ACL Elite/Elite Pro Instrument Family.

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 device.

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