LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170264
    Device Name
    Gold AQ Blood Glucose Monitoring System
    Manufacturer
    Changsha Sinocare Inc.
    Date Cleared
    2017-10-05

    (251 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changsha Sinocare Inc.

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

    The Gold AQ Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. It is intended to be used by people with diabetes at home as an aid in monitoring the effectiveness of their diabetes control programs.

    The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip. The Gold AQ Blood Glucose Monitoring System is for seff-testing outside the body (in vitro diagnostic use).

    The Gold AO Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

    The Gold AQ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.

    Device Description

    The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Gold AQ Blood Glucose Monitoring System, which primarily discusses the regulatory approval of the device. It outlines the device's indications for use and regulatory classifications but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1