Cancer Predisposition Risk Assessment System
The Cancer Predisposition Risk Assessment System is an over-the-counter qualitative in vitro molecular diagnostic system for detecting select variants in specified cancer-related genes from genomic DNA isolated from user-collected specimens, providing a genetic health risk assessment for developing certain cancers; the device is not a comprehensive cancer risk assessment tool and is not intended to direct treatment or substitute for recommended cancer screenings. It is classified as a Class 2 device under regulation 866.6090, requiring 510(k) premarket notification, and falls within the Medical Genetics (MG) medical specialty with Pathology (PA) review. The product code is QAZ. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QAZ
- Device Class
- FDA class 2
- Regulation Number
- 866.6090
- Medical Specialty
- Medical Genetics
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | Aug 31, 2023 | Substantially Equivalent | 23andMe, Inc. |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | Jan 06, 2022 | Substantially Equivalent | 23andMe, Inc. |
| K182784 | MUTYH-Associated Polyposis (MAP) | Jan 18, 2019 | Substantially Equivalent | 23andMe, Inc. |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | Mar 06, 2018 | Unknown | 23andMe, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.