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510(k) Data Aggregation

    K Number
    K050821
    Device Name
    COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
    Manufacturer
    ZYCARE
    Date Cleared
    2005-08-16

    (138 days)

    Product Code
    KQG
    Regulation Number
    864.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZYCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver.
    Device Description
    The CoagCare system is a software accessory to prescription-home use prothrombin time (INR) devices for effective anticoagulation management with warfarin. System Overview: The system consists of two components, the CoagCare Patient Interface and the CoagCare Caregiver Interface, both of which are accessed through an internet browser. The interface provides a structured therapeutic regimen developed for the individual patient. It prompts the patient for INR values, symptoms, and other disease related data, and provides the patient with recommended doses of warfarin and an INR testing schedule that can be adjusted based on parameters specified by the patient's caregiver. The patient is given recommendations for warfarin doses for each day until the next time of required INR testing. In cases of marked abnormal INR readings or disease signs or symptoms suggestive of over-treatment, the Patient Interface instructs the patient to contact his/her healthcare provider for further instructions. The second component of the CoagCare system is the Caregiver Interface. The caregiver monitoring the patient's anticoagulant therapy accesses the Caregiver Interface at least daily. The Caregiver Interface is programmed to automatically identify patient problems such as patients who report thromboembolic or hemorrhagic symptoms, failure to check their INR on a prescribed day, etc. The Caregiver Interface prioritizes problems requiring the caregiver's attention. Once patients have checked their INRs and transmitted their results, if the caregiver agrees with the warfarin dosing instructions provided by the patient interface, no further interventions are required for that day. Patients with markedly abnormal results or recurrent problems are prioritized for caregiver intervention, whereas stable patients are listed with their results, eliminating the need for direct patient contact by the caregiver. The Caregiver Interface also allows the caregiver to override therapeutic instructions provided by the Patient Interface, or send a text message to the patient through the Patient interface. (For more emergent issues, the patient can be contacted directly by the caregiver by telephone.)
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