Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133584
    Device Name
    IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2014-09-08

    (291 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    EOSHEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared. The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip. The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
    Device Description
    The EosHealth, Inc. In Touch® BGMS, is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components: - In Touch® Blood Glucose Meter (In Touch® meter) - In Touch® Blood Glucose Test Strips ● - In Touch® Lancing Device ● - In Touch® Lancets ● - In Touch® Level 1 Control Solution - In Touch® Level 2 Control Solution - AC Adapter (wall charger) and USB Charger - Carrying Case - . In Touch® Data Management System (optional accessory to the In Touch® BGMS) The In Touch® meter is an Over-The-Counter (OTC), handheld device that along with the primary components of the system, monitors glucose in the blood to help with the management and treatment of diabetes. The In Touch® meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs, and a pedometer. The test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips. These blood glucose levels are displayed on the screen and stored in In Touch® meter's memory. In addition to the immediate read-out on In Touch® meter's display, the readings can also be transmitted securely over the GSM cellular network to a secure server. The use on the GMS connection also provides the ability for direct feedback from the server to the In Touch® meter.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1