DEN220023 is an FDA 510(k) submission for the Procise ADL. This device is classified as a Adalimumab Assay (Class II - Special Controls, product code QYD).
Submitted by Procisedx, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2023.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3115. An In Vitro Diagnostic Device Intended For The Measurement Of Adalimumab, An Anti-tumor Necrosis Factor Alpha Monoclonal Antibody.
| 510(k) Number | DEN220023 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 04, 2022 |
| Decision Date | September 29, 2023 |
| Days to Decision | 543 days |
| Submission Type | Direct |
| Review Panel | Toxicology (TX) |
| Summary | - |
| Product Code | QYD - Adalimumab Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3115 |
| Definition | An In Vitro Diagnostic Device Intended For The Measurement Of Adalimumab, An Anti-tumor Necrosis Factor Alpha Monoclonal Antibody |