DEN190032 is an FDA 510(k) submission for the HemosIL Liquid Anti-Xa. This device is classified as a Anti-factor Xa Activity Test System, Apixaban (Class II - Special Controls, product code QLU).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Not Cleared (DENG) decision on September 17, 2020.
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 | DEN190032 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 25, 2019 |
| Decision Date | September 17, 2020 |
| Days to Decision | 450 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | — |
| 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. |