K192063 is an FDA 510(k) clearance for the PGDx elio tissue complete. This device is classified as a Next Generation Sequencing Based Tumor Profiling Test (Class II - Special Controls, product code PZM).
Submitted by Personal Genome Diagnostics (Baltimore, US). The FDA issued a Cleared decision on April 24, 2020, 267 days after receiving the submission on August 1, 2019.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6080. A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing..
| 510(k) Number | K192063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2019 |
| Decision Date | April 24, 2020 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | PZM - Next Generation Sequencing Based Tumor Profiling Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6080 |
| Definition | A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing. |