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510(k) Data Aggregation

    K Number
    K171450
    Device Name
    Glooko Mobile Insulin Dosing System
    Manufacturer
    Glooko, Inc
    Date Cleared
    2018-02-02

    (261 days)

    Product Code
    NDC, CLA
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Glooko, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
    Device Description
    The Glooko MIDS system will be an optional new module to support the titration of long acting basal insulin doses. Health care providers (HCPs) will be able to opt-in to this new MIDS module and use it with a subset of their patients. Although the Glooko App may interact with Blood Glucose (BG) meters, insulin pumps and Continuous Glucose Meters (CGM), the MIDS interface will get data ONLY from the BG meters. Glooko MIDS consists of the following two interfaces: - MIDS Provider Interface on the Glooko Web Application for use by HCP's to prescribe long acting insulin doses for their patients - MIDS Patient interface on the Glooko mobile application for use by patients on compatible iOS and Android phones Glooko MIDS provides directions to the patient based on a pre-planned treatment program as suggested by their HCP for titrating long acting insulin doses. Glooko MIDS is for titrating long acting insulin doses only.
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    K Number
    K132272
    Device Name
    GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
    Manufacturer
    GLOOKO, INC.
    Date Cleared
    2013-10-17

    (87 days)

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

    GLOOKO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System. The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
    Device Description
    The Glooko device system for Glooko Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their Android Operating System mobile devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice. The Glooko device system for Glooko Application consists of the following components: 1. The Glooko MeterSync Cable for Android 2. The Glooko Application
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    K Number
    K130886
    Device Name
    GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
    Manufacturer
    GLOOKO, INC.
    Date Cleared
    2013-04-25

    (27 days)

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

    GLOOKO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform. The Glooko device system for Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
    Device Description
    The Glooko device system for Glooko Logbook+ Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their iPhone Operating System (iOS) devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Logbook+ Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice. The Glooko device system for Logbook+ Application consists of the following components: 1. The Glooko MeterSync Cable 2. The Glooko IR Adapter 3. The Glooko Logbook+ Application
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    K Number
    K122142
    Device Name
    GLOOKO LOGBOOK CHARTS
    Manufacturer
    GLOOKO, INC.
    Date Cleared
    2012-12-21

    (155 days)

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

    GLOOKO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for the Glooko Logbook Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform. The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts are not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
    Device Description
    The Glooko device system for the Glooko Logbook Application includes the following: - . Glooko MeterSync Cable - . Glooko IR Adapter - . Glooko Logbook Application The Glooko™ Logbook Charts is a data management software tool designed to assist people with diabetes who self-manage their Blood Glucose (BG) readings. The Logbook Charts software is used in conjunction with the Glooko MeterSync Cable and the Glooko Logbook Application. The MeterSync Cable and the Glooko Logbook Application allow users to download BG readings from commercially available blood glucose meters to an iOS (iPhone Operating System) device. The Glooko Logbook Charts software tool enables the Glooko Logbook Application users to chart and graph their BG values from the Glooko Logbook Application. Glooko Logbook Charts is a spreadsheet program developed in Microsoft Excel and helps with quantitatively evaluating the BG data downloaded into the Glooko Logbook Application. Users can download the Glooko Logbook Charts sheet template from the Glooko website to generate and display reports on average BG values and BG trends. Several statistical parameters are calculated and the data is plotted as scattergrams relating blood glucose by time of day and by date. Glooko Logbook Charts specifically offers the following charts and table for view: - a. BG readings By Time of Day: provides an overview of glucose readings during the day. - BG readings By Dote: provides an overview of glucose readings over a specified date b. range. - ﻥ BG readings Analysis By Time Of Day: provides an overview of analyzed glucose readings during the day with high and low values, percentiles, mean and medians. BG readings Summary Statistics: provides an overview of the analyzed glucose readings in table format.
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