# Direct-To-Consumer Access Pharmacogenetic Assessment System
> **Product code: QDJ** · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 862.3364
## Classification
- **FDA Product Code:** QDJ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.3364
- **Review panel:** CH
- **Medical specialty:** Medical Genetics
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QDJ)
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