Devices · Geneseeq Technology Inc.

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

Geneseeq Technology Inc. is listed for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (K250003). The FDA list gives August 29, 2025 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PZM as “Next Generation Sequencing Based Tumor Profiling Test”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250003

Official FDA database record

Date of final decision

August 29, 2025

Company on the FDA list

Geneseeq Technology Inc.

Lead panel

Pathology

Primary product code

PZM

openFDA device name for the code

Next Generation Sequencing Based Tumor Profiling Test

Device class

2

Regulation number

866.6080

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary