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U.S. Department of Health and Human Services

Product Classification

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Device continuous glucose monitor informed insulin dose calculator
Regulation Description Insulin therapy adjustment device.
Definition A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.
Physical State Software as a medical device.
Technical Method Software algorithm.
Target Area Software.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQRX
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1358
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
Third Party Review Not Third Party Eligible