Cancer Predisposition Risk Assessment System
Medical Genetics · 21 CFR 866.6090
A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a persons overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- 23AndMe, Inc.Aug 31, 2023
K223597 · 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- 23AndMe, Inc.Jan 6, 2022
K211499 · 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
- 23AndMe, Inc.Jan 18, 2019
K182784 · MUTYH-Associated Polyposis (MAP)
- 23AndMe, Inc.Mar 6, 2018
DEN170046 · 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)