PZM

Next Generation Sequencing Based Tumor Profiling Test

Product code

PZM

Device name

Next Generation Sequencing Based Tumor Profiling Test

Device class

Class 2

21 CFR

21 CFR 866.6080

Medical specialty

Pathology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

8

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-05-12.

2 summaries are archived here for direct download.