DeviceClearance

Product code PZM— Pathology

ACTOnco, ACTOnco IVD

Classification name
Next Generation Sequencing Based Tumor Profiling Test
Device class
Class 2
Regulation
21 CFR 866.6080
Advisory panel
Pathology
Total cleared
8
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PZM under 21 CFR 866.6080, via openFDA

Market context for product code PZM

FDA has cleared 8 devices under product code PZM between 2017 and 2026, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZM

Recent clearances under product code PZM

Data sourced from openFDA. This site is unofficial and independent of the FDA.