DEN230024 is an FDA 510(k) submission for the Technozym ADAMTS13 Activity. This device is classified as a Adamts13 Activity Test System (Class II - Special Controls, product code SAC).
Submitted by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM (Vienna, AT). The FDA issued a Not Cleared (DENG) decision on February 28, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7297. An Adamts13 Activity Test System Is A Qualitative Or Quantitative In Vitro Diagnostic Device Intended To Detect Adamts13 Activity In Human Blood Specimens Collected From Patients Being Evaluated For Thrombotic Microangiopathy. This Device Is Indicated To Aid In The Diagnosis And Management Of Patients Being Evaluated For Thrombotic Thrombocytopenic Purpura In Conjunction With Other Clinical And Laboratory Findings..
| 510(k) Number | DEN230024 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 06, 2023 |
| Decision Date | February 28, 2024 |
| Days to Decision | 328 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | - |
| Product Code | SAC - Adamts13 Activity Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7297 |
| Definition | An Adamts13 Activity Test System Is A Qualitative Or Quantitative In Vitro Diagnostic Device Intended To Detect Adamts13 Activity In Human Blood Specimens Collected From Patients Being Evaluated For Thrombotic Microangiopathy. This Device Is Indicated To Aid In The Diagnosis And Management Of Patients Being Evaluated For Thrombotic Thrombocytopenic Purpura In Conjunction With Other Clinical And Laboratory Findings. |