Next Generation Sequencing Based Tumor Profiling Test
The Next Generation Sequencing Based Tumor Profiling Test is a qualitative in vitro diagnostic test intended to detect somatic mutations across a broad panel of targeted genes in tumor specimens from patients diagnosed with malignant solid neoplasms, using targeted next-generation sequencing technology. It is classified as a Class 2 device under regulation 866.6080, requiring 510(k) premarket notification and eligible for third-party review, falling within the Pathology (PA) medical specialty. The product code is PZM. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZM
- Device Class
- FDA class 2
- Regulation Number
- 866.6080
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260235 | CellDx-Tissue | May 12, 2026 | Substantially Equivalent | Datar Cancer Genetics Private Limited |
| K241868 | xR IVD | Sep 19, 2025 | Substantially Equivalent | Tempus AI, Inc. |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Aug 29, 2025 | Substantially Equivalent | Geneseeq Technology, Inc. |
| K210017 | ACTOnco, ACTOnco IVD | Dec 23, 2022 | Substantially Equivalent | Act Genomics |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | Jul 14, 2021 | Substantially Equivalent | Nyu Langone Medical Center |
| K192063 | PGDx elio tissue complete | Apr 24, 2020 | Substantially Equivalent | Personal Genome Diagnostics |
| K190661 | Omics Core | Nov 09, 2019 | Substantially Equivalent | Nanthealth, Inc. |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Nov 15, 2017 | Unknown | Memorial Sloan-Kettering Cancer Center |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.