PZM · Class II · 21 CFR 866.6080

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., Datar Cancer Genetics Private Limited and Nanthealth, Inc..

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
1–8 of 8
Cleared May 12, 2026
CellDx-Tissue
K260235
Datar Cancer Genetics Private Limited
Pathology · 106d
Cleared Sep 19, 2025
xR IVD
K241868
Tempus AI, Inc.
Pathology · 449d
Cleared Aug 29, 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
K250003
Geneseeq Technology, Inc.
Pathology · 239d
Cleared Dec 23, 2022
ACTOnco, ACTOnco IVD
K210017
Act Genomics
Pathology · 718d
Cleared Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
K202304
Nyu Langone Medical Center
Pathology · 334d
Cleared Apr 24, 2020
PGDx elio tissue complete
K192063
Personal Genome Diagnostics
Pathology · 267d
Cleared Nov 09, 2019
Omics Core
K190661
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 →