FDA Product Code PZJ: Lynch Syndrome Test System
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
Leading manufacturers include Ventana Medical Systems, Promega Corporation and Biocartis NV.
4
Total
3
Cleared
470d
Avg days
2017
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Lynch Syndrome Test System Devices (Product Code PZJ)
4 devices
Cleared
Feb 27, 2023
Idylla MSI Test
Biocartis NV
Pathology
678d
Cleared
Feb 21, 2023
BOND MMR Antibody Panel
Leica Biosystems Newcastle, Ltd.
Pathology
501d
Cleared
Jul 26, 2021
OncoMate MSI Dx Analysis System
Promega Corporation
Pathology
552d
Not Cleared
Oct 27, 2017
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
Ventana Medical Systems
Pathology
150d
About Product Code PZJ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PZJ since 2017, with 3 receiving FDA clearance (average review time: 470 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.