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510(k) Data Aggregation

    K Number
    K242066
    Device Name
    iSage Rx
    Manufacturer
    Amalgam Rx, Inc
    Date Cleared
    2024-08-21

    (37 days)

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

    Amalgam Rx, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iSage Rx is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers to provide ongoing support for understanding and following a titration plan for the following medications, with the goal of reaching optimal medication dose and/or target fasting blood sugar control: -Basal insulins -Combinations of basal insulin and GLP-1 receptor agonists
    Device Description
    iSage Rx System includes a web-based, HIPAA-compliant, password protected Health Care Provider (HCP), Account Administrated websites, and a patient mobile app. The system was designed to enable HCPs to digitize and deploy their basal insulin titration plan such that adult patients with type 2 diabetes may better understand and follow their basal insulin treatment plan through the iSage Rx app. The iSage Rx patient app is a stand-alone, prescription-use only (Rx-only) software device for use under the direction of a healthcare provider, that has the capability to titrate basal insulin and medications that combine basal insulin and GLP-1 receptor agonists, via rule-based protocols as part of a Titration Plan ordered by a Health Care Provider (HCP). It is intended for use in type 2 diabetes in a nonacute care setting. The primary purpose of the iSage Rx device is to help the patient safely reach their fasting blood glucose targets and reach a maintenance dose of insulin through regular monitoring of blood glucose levels and titration of insulin doses.
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