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 Nanthealth, Inc., Personal Genome Diagnostics and Nyu Langone Medical Center.
8
Total
7
Cleared
301d
Avg days
2017
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
265d
recently vs 322d historically
FDA 510(k) Cleared Next Generation Sequencing Based Tumor Profiling Test Devices (Product Code PZM)
8 devices
Cleared
May 12, 2026
CellDx-Tissue
Datar Cancer Genetics Private Limited
Pathology
106d
Cleared
Sep 19, 2025
xR IVD
Tempus AI, Inc.
Pathology
449d
Cleared
Aug 29, 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Geneseeq Technology, Inc.
Pathology
239d
Cleared
Dec 23, 2022
ACTOnco, ACTOnco IVD
Act Genomics
Pathology
718d
Cleared
Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
Nyu Langone Medical Center
Pathology
334d
Cleared
Apr 24, 2020
PGDx elio tissue complete
Personal Genome Diagnostics
Pathology
267d
Cleared
Nov 09, 2019
Omics Core
Nanthealth, Inc.
Pathology
240d
About Product Code PZM - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PZM since 2017, with 7 receiving FDA clearance (average review time: 301 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PZM Product Code
Recent submissions under PZM have taken an average of 265 days to reach a decision - down from 322 days historically, suggesting improved FDA processing for this classification.
PZM devices are reviewed by the Pathology panel. Browse all Pathology devices →