# K182784: MUTYH-Associated Polyposis (MAP)

- Pathway: 510(k) (Traditional)
- Applicant: 23AndMe, Inc.
- Decided: Jan 18, 2019 after 109 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: 1 generation back to DEN170046 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- 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 MUTYH-Associated Polyposis. The 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis is indicated for reporting of the Y179C and the G396D variants in the MUTYH gene. The report describes if a person is at increased risk of developing colorectal cancer. The two variants included in this report are most common and best studied in people of Northern European descent and may not represent the majority of the MUTYH variants found in people of other ethnicities. 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/K182784
Methodology: https://510kreport.com/methodology