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U.S. Department of Health and Human Services

Product Classification

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Device interoperable automated glycemic controller, insulin suspend
Definition An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Physical State This is a software device used to control a compatible insulin pump based on inputs from compatible glucose monitor.
Technical Method Works interoperably with an integrated continuous glucose monitor to measure glucose levels and suspend or resume insulin delivery from an alternate controller enabled insulin pump.
Target Area Standalone software
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQJS
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1356
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
Third Party Review Not Third Party Eligible
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