510(k) DEN210011
DEN210011 is an FDA 510(k) premarket notification submitted by Invitae Corporation for the device "Invitae Common Hereditary Cancers Panel". The FDA issued a decision of De Novo Granted on September 29, 2023. The device falls under product code QVU (High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.), a Class II device regulated under 21 CFR 866.6095.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 29, 2023
- Date Received
- March 29, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
- Device Class
- Class II
- Regulation Number
- 866.6095
- Review Panel
- PA
- Submission Type
A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.