Next Generation Sequencing Based Tumor Profiling Test

PZM is the FDA product code for Next Generation Sequencing Based Tumor Profiling Test, a class II device type, regulated under 21 CFR 866.6080. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2026-05-12, and no recalls.