QFK — Tumor Gene Profiling Test Class N
FDA product code QFK covers "Tumor Gene Profiling Test", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QFK
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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 nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing.