Direct-To-Consumer Access Pharmacogenetic Assessment System
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.