FDA product code NXG: Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
NXG is the FDA product code for fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion. It is a Class III device, reviewed by the Pathology panel. Devices under NXG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NXG devices
openFDA lists no recalls for product code NXG.
Frequently asked questions
What is FDA product code NXG?
NXG is the FDA product code for fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion. It is a Class III device, reviewed by the Pathology panel.
What device class is NXG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NXG
- Run a recall and safety report across every NXG manufacturer
- Watch product code NXG 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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