QLU — Anti-Factor Xa Activity Test System, Apixaban Class II
FDA product code QLU covers "Anti-Factor Xa Activity Test System, Apixaban", a Class II medical device regulated under 21 CFR 864.7295. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QLU
- Device Class
- Class II
- Regulation Number
- 864.7295
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240315 | siemens healthcare diagnostics products | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api | October 10, 2024 |
| K223187 | instrumentation laboratory | HemosIL Liquid Anti-Xa | June 23, 2023 |
| DEN190032 | instrumentation laboratory | HemosIL Liquid Anti-Xa | September 17, 2020 |