Cleared Traditional

Omics Core

K190661 · Nanthealth, Inc. · Pathology

Nov 2019

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K190661 is an FDA 510(k) clearance for the Omics Core, a Next Generation Sequencing Based Tumor Profiling Test (Class II — Special Controls, product code PZM), submitted by Nanthealth, Inc. (Culver City, US). The FDA issued a Cleared decision on November 9, 2019, 240 days after receiving the submission on March 14, 2019. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6080.

Submission Details

510(k) Number	K190661 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2019
Decision Date	November 09, 2019
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

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.