510(k) · Cleared
Cleared23andMe 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
Cleared on Oct 26, 2022 as substantially equivalent to K193492 (23AndMe, Inc., 2020) after a 119-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Oct 26, 2022
- Review
- 119 days
- Class
- Class II
- Product code
- QDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180028 (2018). No later device cites it as a predicate yet.
- Root · 2 generations backDEN180028 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2018
- 1 generation backK193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2020
- This deviceK221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2018 | — |
| −1 | K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2020 | — |
| 0 (this device) | K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | 2022 | — |
Sources: FDA 510(k) 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 K193492 23andMe Personal Genome Service (PGS)…score 2.9 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic ReportsSummary page 6…Class II 23andMe Pharmacogenetic Reports cleared on August 17, Predicate Device: 2020 under K193492 5.2. INTENDED USE The 23andMe Personal Genome Service (PGS) is a qualitative genotyping assessment system applied to genomic… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
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. 2022, 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 (328 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: CYP2C19
Variant(s): *2, *3, *17
Gene: CYP2C9
Variant(s): *2, *3, *5, *6, rs7089580
Gene: CYP3A5
Variant(s): *3
Gene: UGT1A1
Variant(s): *6, *28
Gene: DPYD
Variant(s):*2A, rs67376798
Gene: TPMT
Variant(s): *2, *3C
Gene: SLCO1B1
Variant(s): c.521T>C (rs4149056)
Gene: CYP2D6
Variant(s): *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.
The 23andMe Personal Genome Service pharmacogenetic reports for CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT and CYP2D6 describe 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.
23andMe Personal Genome Service pharmacogenetics report for CYP2C19 describes if a person has variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of the identified metabolizer phenotype on citalopram and clopidogrel therapy.
23andMe Personal Genome Service pharmacogenetics report for SLCO1B1 describes if a person has variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of the identified transport function phenotype on simvastatin therapy.
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/K221885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221885: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221885
Report an extraction error
Are you the manufacturer?
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