Cleared Traditional

K250003 - GENESEEQPRIME NGS Tumor Profiling Assay...

K250003 is an FDA 510(k) clearance for GENESEEQPRIME NGS Tumor Profiling Assay..., manufactured by Geneseeq Technology, Inc.. The device is a Class 2 Pathology device with product code PZM cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K250003 · Geneseeq Technology, Inc. · Pathology device
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Aug 2025
Decision
239d
Days
Class 2
Risk

K250003 is an FDA 510(k) clearance for the GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005). Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Geneseeq Technology, Inc. (Toronto, CA). The FDA issued a Cleared decision on August 29, 2025 after a review of 239 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6080 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Geneseeq Technology, Inc. devices

FDA 510(k) Submission Details - K250003

510(k) Number K250003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 77d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZM Device Classification - Class 2, Special Controls

Product Code PZM Next Generation Sequencing Based Tumor Profiling Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

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