Direct-To-Consumer Access Pharmacogenetic Assessment System
QDJ is the FDA product code for Direct-To-Consumer Access Pharmacogenetic Assessment System, a class II device type, regulated under 21 CFR 862.3364. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QDJ
- Device name
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- FDA 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.
- Regulation
- 21 CFR 862.3364
- Device class
- Class II
- Review panel
- Medical Genetics
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code QDJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code QDJ| Applicant | Clearances |
|---|---|
| 23AndMe, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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