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U.S. Department of Health and Human Services

Product Classification

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Device insulin pump therapy adjustment calculator for healthcare professionals
Regulation Description Insulin therapy adjustment device.
Definition An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors.
Physical State The device is software with a graphical user interface.
Technical Method Software algorithm
Target Area Diabetes
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQCC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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