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    K Number
    K191038
    Device Name
    On Call Express Voice Blood Glucose Monitoring System
    Manufacturer
    ACON Laboratories, Inc.
    Date Cleared
    2019-06-12

    (55 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    On Call Express Voice Blood Glucose Monitoring System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The On Call® Express Voice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steadystate times (when blood glucose level is not changing rapidly).

    The On Call® Express Voice Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

    The On Call® Express Voice Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes the FDA 510(k) clearance for the On Call® Express Voice Blood Glucose Monitoring System but does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

    The document is a clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use. However, it does not include the performance data, study design, or specific thresholds that would typically be found in a study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them based solely on the provided text. The requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth type, training set size, and training set ground truth establishment is not present in this document.

    To obtain that information, one would typically need to refer to the full 510(k) submission, which is not provided here.

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