K223187 is an FDA 510(k) clearance 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 Cleared decision on June 23, 2023, 254 days after receiving the submission on October 12, 2022.
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 | K223187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2022 |
| Decision Date | June 23, 2023 |
| Days to Decision | 254 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. |