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U.S. Department of Health and Human Services

Product Classification

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Device integrated continuous glucose monitoring system for non-intensive diabetes management
Regulation Description Integrated continuous glucose monitoring system.
Definition An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
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 Diagnosis, monitoring
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQDK
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