Pathology · 510(k) · 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Geneseeq Technology Inc.. Cleared by FDA on 29 August 2025 under submission K250003, product code PZM (next generation sequencing based tumor profiling test). What FDA's record says, in FDA's words.
Device record · K250003
- Device. GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)DEVICE
- Company. Geneseeq Technology Inc. (CA)COMPANY
- Decision. 29 August 2025, 510(k), substantially equivalent (traditional review); received 2 January 2025DECISION
- Panel. PathologyPANEL
- Product code. PZM, Next Generation Sequencing Based Tumor Profiling TestCODE
- Regulation. 21 CFR 866.6080, Class IIREG
- Source. FDA database entry · decision document (72 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PZM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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