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U.S. Department of Health and Human Services

Product Classification

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Device integrated continuous glucose monitoring system, factory calibrated
Regulation Description Integrated continuous glucose monitoring system.
Definition An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
Physical State Glucose sensor, a transmitter, and a primary receiver. The device contains software to calculate glucose values.
Technical Method A transcutaneous glucose sensor which is factory calibrated. The sensor is inserted at home by the end user, and is used in conjunction with the associated transmitter and receiver to monitor glucose levels for the management of diabetes.
Target Area Diagnostics
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQBJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1355
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible