GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is an AI-enabled medical device from Geneseeq Technology Inc. that the U.S. FDA cleared through 510(k) K250003 on August 29, 2025. Its lead review panel is Pathology and its primary product code is PZM (Next Generation Sequencing Based Tumor Profiling Test).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | K250003 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Geneseeq Technology Inc. |
| Lead review panel | Pathology |
| Primary product code | PZM — Next Generation Sequencing Based Tumor Profiling Test |
| Applicant (openFDA) | Geneseeq Technology, Inc. |
| Applicant location | Toronto, CA |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.6080 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) went through this pathway (K250003).
openFDA lists it as a Class 2 device under 21 CFR 866.6080. Class II devices are moderate risk and are subject to general and special controls.
Product code PZM covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Geneseeq Technology Inc. has 1 AI-enabled device on the list, and the Pathology panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.