PZJ — Lynch Syndrome Test System Class II
FDA product code PZJ covers "Lynch Syndrome Test System", a Class II medical device regulated under 21 CFR 864.1866. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZJ
- Device Class
- Class II
- Regulation Number
- 864.1866
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211181 | biocartis | Idylla MSI Test | February 27, 2023 |
| K213348 | leica biosystems newcastle | BOND MMR Antibody Panel | February 21, 2023 |
| K200129 | promega corporation | OncoMate MSI Dx Analysis System | July 26, 2021 |
| DEN170030 | ventana medical systems | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 | October 27, 2017 |