meddevicedb.com FDA Device Reference

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

DEN170058 Class II Direct
Decision Date
2017-11-15
Sponsor / Applicant
Memorial Sloan-Kettering Cancer Center

Technical Specification

510(k) Submission ID DEN170058
Product Code PZM
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 866.6080
Decision Date 2017-11-15
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay received FDA 510(k) clearance under submission number DEN170058, sponsored by Memorial Sloan-Kettering Cancer Center. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2017-11-15.

Classification & Regulation

This clearance is catalogued under FDA product code PZM and 21 CFR 866.6080, within the Pathology review panel as a Class II device.