DEN200062 is an FDA 510(k) submission for the Parsortix PC1 Device. This device is classified as a Circulating Tumor Cell (ctc) Enrichment Device (Class II - Special Controls, product code QSA).
Submitted by Angle Europe , Ltd. (Guildford, GB). The FDA issued a Not Cleared (DENG) decision on May 24, 2022.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.6110. A Circulating Tumor Cell Enrichment Device Is An In Vitro Diagnostic Device Used To Enrich Circulating Tumor Cells From The Peripheral Blood Of Patients Diagnosed With Cancer For Subsequent In Vitro Diagnostic Testing..
| 510(k) Number | DEN200062 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 28, 2020 |
| Decision Date | May 24, 2022 |
| Days to Decision | 603 days |
| Submission Type | Direct |
| Review Panel | Medical Genetics (MG) |
| Summary | - |
| Product Code | QSA - Circulating Tumor Cell (ctc) Enrichment Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6110 |
| Definition | A Circulating Tumor Cell Enrichment Device Is An In Vitro Diagnostic Device Used To Enrich Circulating Tumor Cells From The Peripheral Blood Of Patients Diagnosed With Cancer For Subsequent In Vitro Diagnostic Testing. |