FDA product code QFK: Tumor Gene Profiling Test
QFK is the FDA product code for tumor gene profiling test. It is a Not classified device, reviewed by the Pathology panel. Devices under QFK reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Tumor Gene Profiling Test |
| Device class | Not classified |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QFK devices
openFDA lists no recalls for product code QFK.
Frequently asked questions
What is FDA product code QFK?
QFK is the FDA product code for tumor gene profiling test. It is a Not classified device, reviewed by the Pathology panel.
What device class is QFK?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QFK
- Run a recall and safety report across every QFK manufacturer
- Watch product code QFK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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