# DEN190032: HemosIL Liquid Anti-Xa

- Pathway: De Novo (Direct)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 17, 2020 after 450 days
- Product code: QLU (Anti-Factor Xa Activity Test System, Apixaban)
- Device class: 2
- Regulation: 21 CFR 864.7295
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213464: HemosIL Liquid Anti-Xa (2022), 2 descendants of its own
- 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

## Indications for use
HemosIL 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 HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family, ACL TOP Family 50 Series, and ACL Elite/Elite Pro. • When used with HemosIL 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 HemosIL 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/DEN190032
Methodology: https://510kreport.com/methodology