FDA product code QXC: Diabetes Digital Therapeutic Device
QXC is the FDA product code for diabetes digital therapeutic device. It is a Class II device, regulated under 21 CFR 880.5735 and reviewed by the Clinical Chemistry panel. Devices under QXC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.
Classification
| Field | Value |
|---|---|
| Device name | Diabetes Digital Therapeutic Device |
| Device class | Class II |
| Regulation | 21 CFR 880.5735 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QXC devices
openFDA lists no recalls for product code QXC.
Frequently asked questions
What is FDA product code QXC?
QXC is the FDA product code for diabetes digital therapeutic device. It is a Class II device, regulated under 21 CFR 880.5735 and reviewed by the Clinical Chemistry panel.
What device class is QXC?
Class II, regulation 21 CFR 880.5735. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXC
- Run a recall and safety report across every QXC manufacturer
- Watch product code QXC 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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