# K213464: HemosIL Liquid Anti-Xa

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 4, 2022 after 341 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935212 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls, Instrumentation Laboratory CO (2009) Summary page 4.
- DEN190032: HemosIL Liquid Anti-Xa, Instrumentation Laboratory CO (2020) Summary page 4.

## Most influential descendants
- K223187: HemosIL Liquid Anti-Xa (2023), 1 descendant of its own
- K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (2024), 0 descendants of its own

## Recalls of this device
- Feb 3, 2025 · Class II · Z-2323-2025: Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed
- Dec 18, 2024 · Class II · Z-1020-2025: Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

## Indications for use
HemoslL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used: * When used with HemoslL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series. * When used with HemoslL Apixaban Calibrators: Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemoslL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: - Patients at risk for major bleeding - Patients experiencing a bleeding episode The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. For use in adult population. For prescription use only.

Source page: https://510kreport.com/device/K213464
Methodology: https://510kreport.com/methodology