510(k) K182784
K182784 is an FDA 510(k) premarket notification submitted by 23AndMe, Inc. for the device "MUTYH-Associated Polyposis (MAP)". The FDA issued a decision of Substantially Equivalent on Jan 18, 2019. The device falls under product code QAZ (Cancer Predisposition Risk Assessment System), a Class II device regulated under 21 CFR 866.6090. 23AndMe, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2019
- Date Received
- Oct 1, 2018
- Clearance Type
- Traditional
- 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
- 510(k)
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.