# DEN170046: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

- Pathway: De Novo (Direct)
- Applicant: 23AndMe, Inc.
- Decided: Mar 6, 2018 after 182 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K182784: MUTYH-Associated Polyposis (MAP) (2019), 1 descendant of its own
- K223597: 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (2023), 0 descendants of its own
- K211499: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (2022), 0 descendants of its own

## 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 with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of BRCA1/BRCA2 variants in the general population. 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 to determine any treatments.

Source page: https://510kreport.com/device/DEN170046
Methodology: https://510kreport.com/methodology