QAZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cancer Predisposition Risk Assessment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6090
- Medical specialty
- Medical Genetics
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (K223597) | 23AndMe, Inc. | 2023-08-31 |
| 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (K211499) | 23AndMe, Inc. | 2022-01-06 |
| MUTYH-Associated Polyposis (MAP) (K182784) | 23AndMe, Inc. | 2019-01-18 |
| 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (DEN170046) | 23AndMe, Inc. | 2018-03-06 |
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Every clearance here is in the API, with alerts when new ones post.