510(k) K250003
K250003 is an FDA 510(k) premarket notification submitted by Geneseeq Technology, Inc. for the device "GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code PZM (Next Generation Sequencing Based Tumor Profiling Test), a Class II device regulated under 21 CFR 866.6080.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2025
- Date Received
- January 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Next Generation Sequencing Based Tumor Profiling Test
- Device Class
- Class II
- Regulation Number
- 866.6080
- Review Panel
- PA
- Submission Type
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.