# Genetic Variant Detection And Health Risk Assessment System
> **Product code: PTA** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5950
## Classification
- **FDA Product Code:** PTA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5950
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 8
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PTA)
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