Cleared Traditional

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

K202304 · Nyu Langone Medical Center · Pathology

Jul 2021

Decision

334d

Days

Class 2

Risk

About This 510(k) Submission

K202304 is an FDA 510(k) clearance for the NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets), a Next Generation Sequencing Based Tumor Profiling Test (Class II — Special Controls, product code PZM), submitted by Nyu Langone Medical Center (New York, US). The FDA issued a Cleared decision on July 14, 2021, 334 days after receiving the submission on August 14, 2020. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6080.

Submission Details

510(k) Number	K202304 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2020
Decision Date	July 14, 2021
Days to Decision	334 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement

Device Classification

Product Code	PZM — Next Generation Sequencing Based Tumor Profiling Test
Device Class	Class II — 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.