# Lynch Syndrome Test System
> **Product code: PZJ** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 864.1866
## Classification
- **FDA Product Code:** PZJ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.1866
- **Review panel:** PA
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The Lynch syndrome test system is used to identify loss of  DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PZJ)
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