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510(k) Data Aggregation

    K Number
    K984527
    Device Name
    IN TOUCH DIABETES MANAGEMENT SOFTWARE
    Manufacturer
    LIFESCAN, INC.
    Date Cleared
    1999-04-29

    (129 days)

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

    IN TOUCH DIABETES MANAGEMENT SOFTWARE

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

    The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan Brand blood glucose monitoring systems with data management capabilities.

    Device Description

    The IN TOUCH Diabetes Management Software System is an optional data management software accessory for use with LifeScan Brand blood glucose monitors such as the ONE TOUCH®, SureStep® and FastTake® Meters. When used with one of these meters, IN TOUCH permits the transfer of data from the glucose meter memory into a computer for enhanced data management capability.

    AI/ML Overview

    The provided text is a 510(k) submission for the IN TOUCH® Diabetes Management Software System. This submission focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating the device meets specific performance-based acceptance criteria through an analytical or clinical validation study.

    Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

    The document primarily describes:

    • Device Description: An optional data management software accessory for LifeScan blood glucose monitors.
    • Intended Use: To aid in the review, analysis, and evaluation of historical blood glucose test results for diabetes management.
    • Substantial Equivalence: Claimed against the LifeScan ONE TOUCH® Profile® Diabetes Tracking System and the MediSense® Precision Link™ Blood Glucose Data Management System.
    • Regulatory Classification: Unclassified accessory to a blood glucose test system (75CGA) and an exemption for a "calculator/data processing module for clinical use" (862.2100) is discussed, though deemed not entirely applicable due to home use.

    In summary, this document does not contain the information requested about acceptance criteria and a study proving the device meets them because it's a 510(k) submission focused on substantial equivalence rather than a detailed performance validation study.

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