510(k) · Cleared
Cleared23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
23AndMe, Inc. · QAZ Cancer Predisposition Risk Assessment System
Cleared on Jan 6, 2022 as substantially equivalent to DEN170046 (23AndMe, Inc., 2018) and 1 other predicate after a 237-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Jan 6, 2022
- Review
- 237 days
- Class
- Class II
- Product code
- QAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN170046 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | 2018 | — |
| −1 | K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | 2019 | — |
| 0 (this device) | K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 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 QAZ? 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 QAZ device
- #1 K223597 23andMe® Personal Genome Service® (PGS®)…score 5.9 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)Summary page 5…t Required Required Product Code PKB PTA QAZ QDJ DEN/510(k) DEN140044 DEN160026 DEN170046, DEN180028, number K182784 K193492 Decision 19Feb2015… | 2018 |
| * | K182784 | MUTYH-Associated Polyposis (MAP)Summary page 5…QAZ QDJ DEN/510(k) DEN140044 DEN160026 DEN170046, DEN180028, number K182784 K193492 Decision 19Feb2015 06Apr2017 06Mar2018, 31Oct2018, Date(s)… | 2019 |
| † | K141410 | Oragene DX Ogd-500.001 | 2015 |
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 3.0 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate DEN170046.
How does its category compare?
All QAZ devicesQAZ Cancer Predisposition Risk 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 · QAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QAZ
Too few QAZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QAZ
No recall names QAZ since 2007.
Adverse event reports per year · QAZ
1in 2024
MAUDE reports naming product code QAZ, 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals >18 years for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13-Related). The 23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13- Related)…
Read the full statement (178 words)
The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals >18 years for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13-Related). The 23andMe PGS Genetic Health Risk Report for Hereditary Prostate Cancer (HOXB13- Related) is indicated for reporting of the G84E variant in the HOXB13 gene. The report describes if a person has the G84E variant and if a male is at increased risk for prostate cancer. The variant included in this report is most common in people of European descent. The test report does not describe a person's overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer-related. This test is not a substitute for visits to a healthcare provider for recommended screenings or appropriate follow-up and should not be used for diagnosis, to determine any treatments or medical interventions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211499: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211499
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