Not Cleared Direct

DEN170058 - MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170058 · Memorial Sloan-Kettering Cancer Center · Pathology device
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Nov 2017
Decision
51d
Days
Class 2
Risk

DEN170058 is an FDA 510(k) submission (not cleared) for the MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hyb.... Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Memorial Sloan-Kettering Cancer Center (New York, US). The FDA issued a Not Cleared (DENG) decision on November 15, 2017 after a review of 51 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6080 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

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Submission Details

510(k) Number DEN170058 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 25, 2017
Decision Date November 15, 2017
Days to Decision 51 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 77d · This submission: 51d
Pathway characteristics

Device Classification

Product Code PZM Next Generation Sequencing Based Tumor Profiling Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6080
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.