K240315 is an FDA 510(k) clearance for the INNOVANCE Anti-Xa (OPPU05). This device is classified as a Anti-factor Xa Activity Test System, Apixaban (Class II - Special Controls, product code QLU).
Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on October 10, 2024, 251 days after receiving the submission on February 2, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7295. 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..
| 510(k) Number | K240315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2024 |
| Decision Date | October 10, 2024 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | QLU — Anti-factor Xa Activity Test System, Apixaban |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7295 |
| 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. |