Next Generation Sequencing Based Tumor Profiling Test
FDA product code PZM · Class II (moderate risk) · 21 CFR 866.6080 · Pathology
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.
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260235 | CellDx-TissuePZM · Traditional | Datar Cancer Genetics Private Limited | 05/12/2026SE |
| K241868 | xR IVDPZM · Traditional | Tempus AI, Inc. | 09/19/2025SE |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)PZM · Traditional | Geneseeq Technology, Inc. | 08/29/2025SE |
| K210017 | ACTOnco, ACTOnco IVDPZM · Traditional | Act Genomics | 12/23/2022SE |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)PZM · Traditional | Nyu Langone Medical Center | 07/14/2021SE |
| K192063 | PGDx elio tissue completePZM · Traditional | Personal Genome Diagnostics | 04/24/2020SE |
| K190661 | Omics CorePZM · Traditional | Nanthealth, Inc. | 11/09/2019SE |