PZM — Next Generation Sequencing Based Tumor Profiling Test Class II
Classification Details
- Product Code
- PZM
- Device Class
- Class II
- Regulation Number
- 866.6080
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241868 | tempus ai | xR IVD | September 19, 2025 |
| K250003 | geneseeq technology | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | August 29, 2025 |
| K210017 | act genomics | ACTOnco, ACTOnco IVD | December 23, 2022 |
| K202304 | nyu langone medical center | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | July 14, 2021 |
| K192063 | personal genome diagnostics | PGDx elio tissue complete | April 24, 2020 |
| K190661 | nanthealth | Omics Core | November 9, 2019 |
| DEN170058 | memorial sloan-kettering cancer center | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybrid | November 15, 2017 |