MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

DEN170058 is the FDA 510(k) clearance record for MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay, a class II device, cleared for Memorial Sloan-Kettering Cancer Center on 2017-11-15 under FDA product code PZM (Next Generation Sequencing Based Tumor Profiling Test). FDA's definition for product code PZM 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...". FDA records list one 510(k) clearance for Memorial Sloan-Kettering Cancer Center. As of 2026-09-10, FDA records show no recalls naming DEN170058.