# DEN170058: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

- Pathway: De Novo (Direct)
- Applicant: Memorial Sloan-Kettering Cancer Center
- Decided: Nov 15, 2017 after 51 days
- Product code: PZM (Next Generation Sequencing Based Tumor Profiling Test)
- Device class: 2
- Regulation: 21 CFR 866.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K192063: PGDx elio tissue complete (2020), 1 descendant of its own
- K260235: CellDx-Tissue (2026), 0 descendants of its own
- K241868: xR IVD (2025), 0 descendants of its own
- K250003: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (2025), 0 descendants of its own
- K210017: ACTOnco, ACTOnco IVD (2022), 0 descendants of its own

## Indications for use
The MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed at Memorial Sloan Kettering Cancer Center.

Source page: https://510kreport.com/device/DEN170058
Methodology: https://510kreport.com/methodology