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510(k) Data Aggregation

    K Number
    K111932
    Device Name
    IGLUCOSE SYSTEM
    Date Cleared
    2011-11-10

    (125 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    POSITIVEID CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings. The iglucose™ System does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
    Device Description
    The iglucose™ System is designed to assist individuals with diabetes with their record keeping management, by automatically tracking and storing historical blood glucose readings. It has been developed for home or health care facility settings as an aid in supporting diabetes management. iglucose™ is designed to connect to glucose meters and automatically transmit blood glucose reading(s) to a secure database. Users can then utilize the iglucoe™ diabetes management portal (web-based application) to view their blood glucose readings as well as to generate and display reports. At the user's discretion, authorized individuals can also view blood glucose readings and reports. More specifically, the iglucose™ System is comprised of the following: - · iglucose™ Device - · Secure Database - ·iglucose™ Diabetes Management Portal (web-based application) The iglucose device is approximately the size of a cell phone and has a rechargeable battery. It connects to compatible FDA cleared glucose meters via a data cable and extracts data from a glucose meter. It then wirelessly (via the cellular network) transmits data (blood glucose readings, date and time) from a glucose meter to a secure database. Software used for the database enables the data to be viewable in an organized manner via the iglucose diabetes management portal (web-based application). At the user's discretion, the data can be communicated via email, SMS text message and/or fax. Data can be displayed in a logbook form. In addition, data can be displayed and trended in reports that are in tabular and graphical formats such as line graphs, pie charts and histograms.
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