# K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Oct 10, 2024 after 251 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: 5 generations back to K935212 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
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.
- K223187: HemosIL Liquid Anti-Xa, Instrumentation Laboratory CO (2023) Summary page 5.

## Indications for use
INNOVANCE Anti-Xa assay in combination with INNOVANCE Heparin Calibrator is an In-vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of UFH and LMWH can be performed on the BCS XP System, CS-2500 System, CS-5100 System and the CA‑660 System. For use with plasma from patients undergoing anticoagulant therapy with either UFH or LMWH. INNOVANCE Anti-Xa assay in combination with INNOVANCE Apixaban Standard provides quantitative determination of the concentration of apixaban in human plasma collected from venous blood samples in 3.2 % sodium citrated tubes in the clinical laboratory. The quantitative determination of apixaban can be performed on CS-2500 System. For use with plasma from patients undergoing anticoagulant therapy with apixaban in situations where quantification of apixaban levels may be indicated: • Patient with bleeding, • Patient with risk for bleeding (e.g. during perioperative management), • Patient with conditions affecting pharmacokinetics (e.g. deteriorating renal function, extremes of body weight, treatment with other drugs known to affect pharmacokinetics of apixaban). The performance of this device has not been established in neonate and pediatric patient populations.

Source page: https://510kreport.com/device/K240315
Methodology: https://510kreport.com/methodology