# Cancer-Related Germline Gene Mutation Detection System
> **Product code: PJG** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** PJG
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** PA
- **Medical specialty:** Unknown
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PJG)
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