Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
The Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated is a subcutaneous continuous glucose monitoring sensor intended to determine glucose levels, direction, and rate of change in people with diabetes, factory-calibrated without requiring user calibration. This is a non-adjunctive device, meaning it is indicated to replace information from standard blood glucose monitoring to make diabetes treatment decisions, as well as providing historical glucose data. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to its high-risk, non-adjunctive role in directing therapy; the regulation number field is not populated. The product code is PZE, reviewed by the Clinical Chemistry (CH) panel. It is not an implant and is not life-sustaining.
Research product code PZE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PZE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.