DEN240035 is an FDA 510(k) submission for the ConcizuTrace™ ELISA. This device is classified as a Non-factor Replacement Product Test System (Class II - Special Controls, product code SES).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Not Cleared (DENG) decision on May 22, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7298. A Non-factor Replacement Product Test System Is A Prescription In Vitro Diagnostic Device Intended To Measure Non-factor Replacement Therapeutic Products That Are Indicated For Routine Prophylaxis To Prevent Or Reduce The Frequency Of Bleeding Episodes In Patients With Bleeding Disorders, Including Hemophilia, In Human Blood Specimens To Ensure Appropriate Therapy In Accordance With The Approved Non-factor Replacement Product Labeling..
| 510(k) Number | DEN240035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 01, 2024 |
| Decision Date | May 22, 2025 |
| Days to Decision | 325 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | SES — Non-factor Replacement Product Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7298 |
| Definition | A Non-factor Replacement Product Test System Is A Prescription In Vitro Diagnostic Device Intended To Measure Non-factor Replacement Therapeutic Products That Are Indicated For Routine Prophylaxis To Prevent Or Reduce The Frequency Of Bleeding Episodes In Patients With Bleeding Disorders, Including Hemophilia, In Human Blood Specimens To Ensure Appropriate Therapy In Accordance With The Approved Non-factor Replacement Product Labeling. |