Product code QDJ— Medical Genetics
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Classification name
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- Device class
- Class 2
- Regulation
- 21 CFR 862.3364
- Advisory panel
- Medical Genetics
- Total cleared
- 3
- First cleared
- Most recent
FDA classification 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 context for product code QDJ
FDA has cleared devices under product code QDJ between 2018 and 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2020
- 2018
Top applicants under product code QDJ
Recent clearances under product code QDJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.