Cleared Traditional

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

K250003 · Geneseeq Technology, Inc. · Pathology

Aug 2025

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K250003 is an FDA 510(k) clearance for the GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005), a Next Generation Sequencing Based Tumor Profiling Test (Class II — Special Controls, product code PZM), submitted by Geneseeq Technology, Inc. (Toronto, CA). The FDA issued a Cleared decision on August 29, 2025, 239 days after receiving the submission on January 2, 2025. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6080.

Submission Details

510(k) Number	K250003 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2025
Decision Date	August 29, 2025
Days to Decision	239 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.