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510(k) Data Aggregation

    K Number
    K231476
    Device Name
    TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System
    Manufacturer
    Sinocare Inc.
    Date Cleared
    2023-12-01

    (193 days)

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

    Sinocare Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates. The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip. The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates. The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.
    Device Description
    The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below: (1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function) (2) TRUENESS Blood Glucose Test Strip A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changsha Sinocare Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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