# K223187: HemosIL Liquid Anti-Xa

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 23, 2023 after 254 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
Longest line of descent: 4 generations back to K935212 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites 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)
- DEN190032: HemosIL Liquid Anti-Xa, Instrumentation Laboratory CO (2020) Summary page 5.
- K213464: HemosIL Liquid Anti-Xa, Instrumentation Laboratory CO (2022) Summary page 5.

## Most influential descendants
- 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 and ACL TOP Family 50 Series. • 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 • When used with HemosIL Rivaroxaban Calibrators: Quantitative determination of rivaroxaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of factor Xa activity, which is inversely proportional to the rivaroxaban level. With HemosIL Rivaroxaban Calibrators, the assay is intended to measure rivaroxaban concentrations in patients on rivaroxaban therapy in the following situations where measurement of rivaroxaban 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/K223187
Methodology: https://510kreport.com/methodology