FDA Product Code PZM: Next Generation Sequencing Based Tumor Profiling Test
A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing.
Leading manufacturers include Geneseeq Technology, Inc., Nyu Langone Medical Center and Act Genomics.
FDA 510(k) Cleared Next Generation Sequencing Based Tumor Profiling Test Devices (Product Code PZM)
About Product Code PZM - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PZM since 2017, with 6 receiving FDA clearance (average review time: 328 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PZM submissions have been consistent, averaging 344 days recently vs 322 days historically.
PZM devices are reviewed by the Pathology panel. Browse all Pathology devices →