PQF — Sensor, Glucose, Invasive, Non-Adjunctive Class III
FDA product code PQF covers "Sensor, Glucose, Invasive, Non-Adjunctive", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PQF
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.