K250003 is an FDA 510(k) clearance for the GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005). This device is classified as a Next Generation Sequencing Based Tumor Profiling Test (Class II - Special Controls, product code PZM).
Submitted by Geneseeq Technology, Inc. (Toronto, CA). The FDA issued a Cleared decision on August 29, 2025, 239 days after receiving the submission on January 2, 2025.
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 | K250003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 239 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. |