PZM
8 FDA 510(k) clearances · Product code
267 daysmedian time to decision
718 days90th percentile
8clearances measured
FDA profile
- Official device name
- Next Generation Sequencing Based Tumor Profiling Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6080
- Medical specialty
- Pathology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| CellDx-Tissue (K260235) | Datar Cancer Genetics Private Limited | 2026-05-12 |
| xR IVD (K241868) | Tempus AI, Inc. | 2025-09-19 |
| GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (K250003) | Geneseeq Technology, Inc. | 2025-08-29 |
| ACTOnco, ACTOnco IVD (K210017) | Act Genomics | 2022-12-23 |
| NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (K202304) | Nyu Langone Medical Center | 2021-07-14 |
| PGDx elio tissue complete (K192063) | Personal Genome Diagnostics | 2020-04-24 |
| Omics Core (K190661) | Nanthealth, Inc. | 2019-11-09 |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (DEN170058) | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |
Track PZM automatically
Every clearance here is in the API, with alerts when new ones post.