510(k) K200129
K200129 is an FDA 510(k) premarket notification submitted by Promega Corporation for the device "OncoMate MSI Dx Analysis System". The FDA issued a decision of Substantially Equivalent on July 26, 2021. The device falls under product code PZJ (Lynch Syndrome Test System), a Class II device regulated under 21 CFR 864.1866.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2021
- Date Received
- January 21, 2020
- Clearance Type
- Traditional
- 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