# Next Generation Sequencing Based Tumor Profiling Test
> **Product code: PZM** · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.6080
## Classification
- **FDA Product Code:** PZM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.6080
- **Review panel:** PA
- **Medical specialty:** Pathology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PZM)
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