510(k) K211181
K211181 is an FDA 510(k) premarket notification submitted by Biocartis NV for the device "Idylla MSI Test". The FDA issued a decision of Substantially Equivalent on February 27, 2023. 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
- February 27, 2023
- Date Received
- April 20, 2021
- 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