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U.S. Department of Health and Human Services

Product Classification
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Device hospital continuous glucose monitoring system
Regulation Description Glucose test system.
Definition Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
Physical State The device system is comprised of a cartridge and an instrument that measures and displays the result.
Technical Method The operator connects the device to the blood source of the patient and activates the assay.
Target Area Whole blood.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePYV
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1345
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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