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U.S. Department of Health and Human Services

Product Classification

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Device sensor, glucose, implanted, non-adjunctive use
Definition A non-adjunctive implanted 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.
Physical State This device comprises a subcutaneously implanted sensor containing the glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, a display device that provides glucose values to the user, and a mechanism for transmitting data from the sensor to the display device.
Technical Method Signals from an implanted (subcutaneous) 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 CodeQHJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
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? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible