De Novo · Granted
Granted23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
23AndMe, Inc. · QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System
Granted on Oct 31, 2018 as a new device type through De Novo after a 148-day review. 2 later devices descend from it.
- Decided
- Oct 31, 2018
- Review
- 148 days
- Class
- Class II
- Product code
- QDJ
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN180028 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2018 | — |
| +1 | K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2020 | — |
| +2 | K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDJ device
- #1 K221885 23andMe Personal Genome Service (PGS)…score 4.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K193492 (23AndMe, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QDJ devicesQDJ Direct-To-Consumer Access Pharmacogenetic Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QDJ
Too few QDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QDJ
No recall names QDJ since 2007.
Adverse event reports per year · QDJ
1in 2022
MAUDE reports naming product code QDJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 23andMe Personal Genome Service (PGS) is a qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD-500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare professional. The 23andMe Personal Genome…
Read the full statement (223 words)
The 23andMe Personal Genome Service (PGS) is a qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD-500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare professional. The 23andMe Personal Genome Service Pharmacogenetic Reports are indicated for reporting of the following variants:
Gene Variant(s)
CYP2C19 *2, *3, *17
CYP2C9 *2, *3, *5, *6, rs7089580
CYP3A5 *3
UGT1A1 *6, *28
DPYD *2A, rs67376798
TPMT *2, *3C
SLCO1B1 *5
CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41
This report is for over-the-counter use by adults over the age of 18 and provides genetic information to inform discussions with a healthcare professional about metabolism of therapeutics. This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic. The PGS Pharmacogenetic Reports are not a substitute for visits to a healthcare professional. The information provided by this report should not be used to start, stop, or change any course of treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026