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U.S. Department of Health and Human Services

Product Classification

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Device sensor, glucose, invasive, non-adjunctive
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.
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 CodePQF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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