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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 professional retrospective use
Definition An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
Physical State Sensor, transmitter, receiver
Technical Method Devices stores data to be used later by a healthcare practitioner regarding measured glucose.
Target Area Human tissue
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQDL
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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