510(k) DEN170030
DEN170030 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems for the device "VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody". The FDA issued a decision of De Novo Granted on October 27, 2017. The device falls under product code PZJ (Lynch Syndrome Test System), a Class II device regulated under 21 CFR 864.1866. Ventana Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 27, 2017
- Date Received
- May 30, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lynch Syndrome Test System
- Device Class
- Class II
- Regulation Number
- 864.1866
- Review Panel
- PA
- Submission Type
The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome