510(k) K240315
K240315 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)". The FDA issued a decision of Substantially Equivalent on October 10, 2024. The device falls under product code QLU (Anti-Factor Xa Activity Test System, Apixaban), a Class II device regulated under 21 CFR 864.7295. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2024
- Date Received
- February 2, 2024
- 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.