# K250003: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

- Pathway: 510(k) (Traditional)
- Applicant: Geneseeq Technology, Inc.
- Decided: Aug 29, 2025 after 239 days
- Product code: PZM (Next Generation Sequencing Based Tumor Profiling Test)
- Device class: 2
- Regulation: 21 CFR 866.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170058 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192063: PGDx elio tissue complete, Personal Genome Diagnostics (2020) Summary page 19.

## Indications for use
The GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is a qualitative in vitro diagnostic test kit that uses next generation sequencing of DNA isolated from formalin-fixed paraffin-embedded tumor tissue from previously diagnosed patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. This test is intended to provide tumor mutation profiling information on somatic variants, including single nucleotide variants (SNVs), insertions and deletions (indels), one amplification, four translocations, microsatellite instability (MSI), and tumor mutation burden (TMB). Information provided by GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology. Results from GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.

Source page: https://510kreport.com/device/K250003
Methodology: https://510kreport.com/methodology