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510(k) Data Aggregation

    K Number
    K070088
    Device Name
    ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    APEX BIOTECHNOLOGY CORP.
    Date Cleared
    2007-02-16

    (38 days)

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

    ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM

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

    The Assure 4 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

    Device Description

    Assure 4 consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control. The Assure 4 measures electrical current generated by the interaction of glucose with glucose oxidase in its biosensor test strip. It uses a code chip for strip lot calibration.

    AI/ML Overview

    The provided text describes the Assure 4 Blood Glucose Monitoring System and its modifications compared to the Assure 3, but does not include detailed acceptance criteria or a study proving the device meets specific performance criteria with numerical results.

    The document K070088 is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full study results against explicit acceptance criteria. While it mentions "Clinical testing was done with persons with diabetes in addition to in-house testing for precision, interferences, linearity, altitude effects, hematocrit effects, minimum sample volume, stability, control solution functionality, and temperature and humidity effects," it lacks the specific data, acceptance thresholds, sample sizes, and expert details requested.

    Therefore, many of the requested fields cannot be fully populated from the provided text.

    Here's what can be extracted and what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Not explicitly stated/quantified in provided text)Reported Device Performance (Not explicitly stated/quantified in provided text)
    PrecisionNot specifiedClinical testing performed
    InterferencesNot specifiedClinical testing performed
    LinearityNot specifiedClinical testing performed
    Altitude EffectsNot specifiedClinical testing performed (up to 7,000 ft listed as a characteristic)
    Hematocrit EffectsNot specifiedClinical testing performed (30-55% listed as a characteristic)
    Minimum Sample VolumeNot specified, but Assure 4 changed to 1.5 µL1.5 µL (for Assure 4)
    StabilityNot specifiedClinical testing performed
    Control Solution FunctionalityNot specifiedClinical testing performed
    Temperature & Humidity EffectsNot specifiedClinical testing performed (Operating T° Range: 57-104°F, Humidity:
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