BEUDAMED
    Product Code: QJI FDA class 2 21 CFR 862.1356

    Interoperable Automated Glycemic Controller

    Clinical Chemistry

    The Interoperable Automated Glycemic Controller is a Class 2 Clinical Chemistry device that automatically calculates drug doses based on glucose and other physiological inputs and commands delivery from a connected infusion pump, designed to reliably and securely communicate with digitally connected devices to maintain glycemic control. It requires 510(k) clearance and is regulated under 21 CFR 862.1356, reviewed by the Clinical Chemistry panel. The product code is QJI. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    20
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    9
    Years Active
    6

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    Basic Information

    Product Code
    QJI
    Device Class
    FDA class 2
    Regulation Number
    862.1356
    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 interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 20 510(k) clearances via K numbers.

    K Number Device Name
    K260429 Control-IQ+ technology
    K253701 SmartGuard Technology; Predictive Low Glucose Technology
    K253585 SmartGuard technology; Predictive Low Glucose technology
    K251152 DBLG2
    K251779 Omnipod 5 algorithm
    K251217 SmartGuard technology; Predictive Low Glucose technology
    K250798 Control-IQ+ technology
    K243823 Control-IQ+ technology
    K241777 SmartAdjust™ Technology
    K232741 SmartAdjust(TM) technology
    K232603 CamAPS FX
    K234055 DEKA Loop
    K232382 Control-IQ Technology
    K232224 iLet® Dosing Decision Software
    K220916 iLet® Dosing Decision Software
    K203689 Tidepool Loop
    K220394 SmartAdjust(TM) technology
    K203774 SmartAdjust technology
    K200467 Control-IQ Technology
    DEN190034 Control-IQ Technology

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.