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U.S. Department of Health and Human Services

Product Classification

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Device sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
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.
Physical State This device comprises a skin piercing sensor containing the glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, a display device which provides glucose values to the user and a mechanism for transmitting data from the sensor to the display device.
Technical Method Signals from an invasive (skin piercing) glucose specific biological sensor are algorithmically converted to glucose values which are provided to the user.
Target Area Interstitial fluid.
Review Panel Clinical Chemistry
Product CodePZE
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible