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510(k) Data Aggregation

    K Number
    K990942
    Device Name
    DUET II GLUCOSE CONTROL MONITORING SYSTEM
    Manufacturer
    LXN CORP.
    Date Cleared
    1999-08-02

    (133 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 :

    DUET II GLUCOSE CONTROL MONITORING SYSTEM

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

    The Duet II Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The Duet II Glucose Monitoring System is to be used by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).

    Device Description

    Duet II Glucose Control Monitoring System

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Duet II Glucose Control Monitoring System. It does not contain the specific technical performance data, acceptance criteria, or details of a study proving the device meets those criteria.

    The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its performance has been deemed comparable. However, the letter itself does not provide the performance data or the study details that led to this determination.

    Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the actual 510(k) submission document (or a summary thereof) which typically includes the detailed performance studies.

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