FDA product code QCD: Continuous Glucose Monitor, Implanted, Adjunctive Use
QCD is the FDA product code for continuous glucose monitor, implanted, adjunctive use. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under QCD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Classification
| Field | Value |
|---|---|
| Device name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QCD devices
openFDA lists no recalls for product code QCD.
Frequently asked questions
What is FDA product code QCD?
QCD is the FDA product code for continuous glucose monitor, implanted, adjunctive use. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is QCD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QCD
- Run a recall and safety report across every QCD manufacturer
- Watch product code QCD 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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