FDA product code PZE: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
PZE is the FDA product code for sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under PZE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 3 recalls for PZE devices, 2 initiated in the last five years.
Definition
A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
Classification
| Field | Value |
|---|---|
| Device name | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PZE devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-02-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code PZE?
PZE is the FDA product code for sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is PZE?
Class III. Typical premarket route: PMA.
Have PZE devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-02-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PZE
- Run a recall and safety report across every PZE manufacturer
- Watch product code PZE 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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