Anti-Factor Xa Activity Test System, Apixaban

FDA product code QLU · Class II (moderate risk) · 21 CFR 864.7295 · Hematology

A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…QLU · Traditional Siemens Healthcare Diagnostics Products GmbH10/10/2024SE
K223187HemosIL Liquid Anti-XaQLU · Traditional Instrumentation Laboratory CO06/23/2023SE

Recalls

RecallProductFirmInitiated
Z-0150-2022 Class IIHemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by…Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument… Instrumentation Laboratory08/25/2021Open, Classified