Product code PZJ— Immunology
BOND MMR Antibody Panel
- Classification name
- Lynch Syndrome Test System
- Device class
- Class 2
- Regulation
- 21 CFR 864.1866
- Advisory panel
- Immunology
- Total cleared
- 4
- First cleared
- Most recent
FDA classification 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”
Market context for product code PZJ
FDA has cleared devices under product code PZJ between 2017 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2021
- 2017
Top applicants under product code PZJ
Recent clearances under product code PZJ
- K211181 — Idylla MSI Test
- K213348 — BOND MMR Antibody Panel
- K200129 — OncoMate MSI Dx Analysis System
- DEN170030 — 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.