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510(k) Data Aggregation

    K Number
    K014139
    Device Name
    DIABETES ASSISTANT SOFTWARE
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2002-03-21

    (94 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The software is intended to assist health care professional and people with diabetes review and analyze blood glucose test results. The device is not intended to provide any diagnosis on patient results.

    Device Description

    Accessory to Accu-Chek brand meters that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

    AI/ML Overview

    The provided 510(k) summary for the Diabetes Assistant Software (K014139) does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.

    The submission is focused on demonstrating substantial equivalence to a predicate device (Camit Diabetes Management Software) based on functional similarities and intended use. There is no mention of a clinical or performance study with detailed methodologies, sample sizes, ground truth establishment, or expert involvement to evaluate the device's efficacy or accuracy against specific benchmarks.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

    The document primarily states:

    • Intended use: To assist healthcare professionals and people with diabetes in reviewing and analyzing historical blood glucose test results. It explicitly states the device is "not intended to provide any diagnosis on patient results."
    • Comparison to predicate device: The submission lists features where the Diabetes Assistant Software is similar to the Camit Diabetes Management Software, such as intended use, meters supported, customer support, data storage, reports/graphs, tracking of non-blood glucose data, multiple patient support, password protection, and embedded help.

    This type of submission often relies on the predicate device's established performance and the demonstration that the new device does not introduce new questions of safety or effectiveness.

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