Direct-To-Consumer Access Pharmacogenetic Assessment System
The Direct-To-Consumer Access Pharmacogenetic Assessment System is a qualitative in vitro molecular diagnostic system intended for detecting variants in nucleic acids from human specimens to identify pharmacogenetic associations for the detected variants, designed for direct access testing by lay users without a prescription. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDJ under regulation 862.3364 in the Medical Genetics specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3364
- Medical Specialty
- Medical Genetics
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | Oct 26, 2022 | Substantially Equivalent | 23AndMe, Inc. |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | Aug 17, 2020 | Substantially Equivalent | 23AndMe, Inc. |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | Oct 31, 2018 | Unknown | 23AndMe, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.