QDJ — Direct-To-Consumer Access Pharmacogenetic Assessment System Class II
FDA product code QDJ covers "Direct-To-Consumer Access Pharmacogenetic Assessment System", a Class II medical device regulated under 21 CFR 862.3364. Submissions are reviewed by the Medical Genetics panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QDJ
- Device Class
- Class II
- Regulation Number
- 862.3364
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Medical Genetics
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221885 | 23andme | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | October 26, 2022 |
| K193492 | 23andme | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | August 17, 2020 |
| DEN180028 | 23andme | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | October 31, 2018 |