BEUDAMED
    Product Code: QBJ FDA class 2 21 CFR 862.1355

    Integrated Continuous Glucose Monitoring System, Factory Calibrated

    Clinical Chemistry

    The Integrated Continuous Glucose Monitoring System, Factory Calibrated (iCGM) is an automatic glucose monitoring device intended to measure glucose in bodily fluids continuously or frequently, designed to reliably and securely transmit glucose data to digitally connected devices including automated insulin dosing (closed-loop) systems, for use alone or in conjunction with these devices in managing glycemic control. It is classified as a Class 2 device under regulation 862.1355, requiring 510(k) premarket notification, and falls within the Clinical Chemistry (CH) medical specialty. The product code is QBJ. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    18
    FEI Numbers
    31
    Registration Numbers
    31
    Unique Applicants
    2
    Years Active
    8

    Research product code QBJ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QBJ
    Device Class
    FDA class 2
    Regulation Number
    862.1355
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 18 510(k) clearances via K numbers.

    K Number Device Name
    K261402 Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
    K253737 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    K253710 Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    K243214 Dexcom G7 15 Day Continuous Glucose Monitoring System
    K240902 Dexcom G7 Continuous Glucose Monitoring System
    K233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
    K234133 Dexcom G7 Continuous Glucose Monitoring System
    K231081 Dexcom G7 Continuous Glucose Monitoring (CGM) System
    K223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
    K222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
    K223931 Dexcom G6 Continuous Glucose Monitoring (CGM) System
    K213919 Dexcom G7 Continuous Glucose Monitoring System
    K221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
    K201328 Dexcom G6 Continuous Glucose Monitoring (CGM) System
    K200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
    K191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
    K183206 Dexcom G6 Continuous Glucose Monitoring System
    DEN170088 Dexcom G6 Continuous Glucose Monitoring System

    FEI Numbers

    This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.