DEN230046 is an FDA 510(k) submission for the PGDx elio plasma focus Dx. This device is classified as a High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids (Class II - Special Controls, product code SBY).
Submitted by Personal Genome Diagnostics, Inc. (Blatimore, US). The FDA issued a Not Cleared (DENG) decision on August 1, 2024.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6085. A High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids Is A Qualitative In Vitro Diagnostic Test Intended For Next Generation Sequencing Analysis Of Circulating Cell-free Nucleic Acids From Plasma Samples Collected From Peripheral Whole Blood To Detect Mutations In A Panel Of Targeted Genes To Aid In The Management Of Previously Diagnosed Cancer Patients By Qualified Health Care Professionals. The Results Of The Test Are Not Prescriptive Or Conclusive For Use Of Any Specific Therapeutic Product..
| 510(k) Number | DEN230046 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 30, 2023 |
| Decision Date | August 01, 2024 |
| Days to Decision | 398 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | SBY - High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6085 |
| Definition | A High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids Is A Qualitative In Vitro Diagnostic Test Intended For Next Generation Sequencing Analysis Of Circulating Cell-free Nucleic Acids From Plasma Samples Collected From Peripheral Whole Blood To Detect Mutations In A Panel Of Targeted Genes To Aid In The Management Of Previously Diagnosed Cancer Patients By Qualified Health Care Professionals. The Results Of The Test Are Not Prescriptive Or Conclusive For Use Of Any Specific Therapeutic Product. |