510(k) K250003

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) by Geneseeq Technology, Inc. — Product Code PZM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2025
Date Received: January 2, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Next Generation Sequencing Based Tumor Profiling Test
Device Class: Class II
Regulation Number: 866.6080
Review Panel: PA
Submission Type

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.

Other clearances for product code PZM

K241868 — xR IVD (September 19, 2025)
K210017 — ACTOnco, ACTOnco IVD (December 23, 2022)
K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (July 14, 2021)
K192063 — PGDx elio tissue complete (April 24, 2020)
K190661 — Omics Core (November 9, 2019)
DEN170058 — MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybrid (November 15, 2017)