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U.S. Department of Health and Human Services

Product Classification
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Device sensor, glucose, invasive, component of automated insulin delivery system
Definition The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.
Physical State This device comprises a glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, and a mechanism for transmitting data from the sensor to specific connected devices.
Technical Method Signals from a glucose specific biological sensor are algorithmically converted to glucose values which are transmitted to specific connected devices.
Target Area Diagnostics
Review Panel Clinical Chemistry
Product CodeSFI
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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