FDA product code QDJ: Direct-To-Consumer Access Pharmacogenetic Assessment System
QDJ is the FDA product code for direct-to-consumer access pharmacogenetic assessment system. It is a Class II device, regulated under 21 CFR 862.3364 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under QDJ, 1 in the last five years. The average 510(k) review took 182 days (median 182). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Direct-To-Consumer Access Pharmacogenetic Assessment System |
| Device class | Class II |
| Regulation | 21 CFR 862.3364 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
510(k) clearances per year for QDJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 244 |
| 2022 | 1 | 119 |
Compare with all 510(k) review times · Search every QDJ clearance
Top QDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 23AndMe, Inc. | 2 | 2022-10-26 |
Most recent QDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221885 | 23AndMe, Inc. | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 2022-10-26 | 119 |
| K193492 | 23AndMe, Inc. | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 2020-08-17 | 244 |
Recalls for QDJ devices
openFDA lists no recalls for product code QDJ.
Frequently asked questions
What is FDA product code QDJ?
QDJ is the FDA product code for direct-to-consumer access pharmacogenetic assessment system. It is a Class II device, regulated under 21 CFR 862.3364 and reviewed by the Clinical Chemistry panel.
What device class is QDJ?
Class II, regulation 21 CFR 862.3364. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDJ?
Across 2 cleared submissions the average was 182 days from receipt to decision (median 182).
Which companies have the most QDJ clearances?
23AndMe, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QDJ
- Run a recall and safety report across every QDJ manufacturer
- Watch product code QDJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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