# K211499: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

- Pathway: 510(k) (Traditional)
- Applicant: 23AndMe, Inc.
- Decided: Jan 6, 2022 after 237 days
- Product code: QAZ (Cancer Predisposition Risk Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.6090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170046 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170046: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), 23AndMe, Inc. (2018) Summary page 5.
- K182784: MUTYH-Associated Polyposis (MAP), 23AndMe, Inc. (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K211499
Methodology: https://510kreport.com/methodology