510(k) DEN170046
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 6, 2018
- Date Received
- September 5, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cancer Predisposition Risk Assessment System
- Device Class
- Class II
- Regulation Number
- 866.6090
- Review Panel
- PA
- Submission Type
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.