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510(k) Data Aggregation

    K Number
    K070960
    Device Name
    NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    2007-07-11

    (97 days)

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

    NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM

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

    The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    Nova StatStrip Glucose Test Strips are intended for use only with Nova StatStrip Glucose Hospital Meters for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

    Nova StatStrip Control Solutions is intended for use with Nova StatStrip Glucose Hospital Meters and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

    Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of Nova StatStrip Glucose Hospital Meter Systems. There are five levels of linearity solutions, (Level 2, Level 3, Level 4, and Level 5).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any detailed study results. The document is a 510(k) premarket notification letter from the FDA, along with an "Indications for Use" statement for the Nova StatStrip Xpress Glucose Hospital Meter.

    It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls provisions of the Act.

    Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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