QAZ — Cancer Predisposition Risk Assessment System Class II
Classification Details
- Product Code
- QAZ
- Device Class
- Class II
- Regulation Number
- 866.6090
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Medical Genetics
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223597 | 23andme | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BR | August 31, 2023 |
| K211499 | 23andme | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | January 6, 2022 |
| K182784 | 23andme | MUTYH-Associated Polyposis (MAP) | January 18, 2019 |
| DEN170046 | 23andme | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | March 6, 2018 |