510(k) K223187

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

June 23, 2023

Date Received

October 12, 2022

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Anti-Factor Xa Activity Test System, Apixaban

Device Class

Class II

Regulation Number

864.7295

Review Panel

HE

Submission Type

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.