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510(k) Data Aggregation

    K Number
    K160282
    Device Name
    SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
    Manufacturer
    SD BIOSENSOR
    Date Cleared
    2017-10-17

    (623 days)

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

    SD BIOSENSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use). The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared. SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use). The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals. SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use). The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared. SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use). The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides. SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.
    Device Description
    SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable. The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor. There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing. The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.
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    K Number
    K153201
    Device Name
    SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
    Manufacturer
    SD BIOSENSOR
    Date Cleared
    2016-06-24

    (233 days)

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

    SD BIOSENSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor BT Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor BT Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
    Device Description
    SD GlucoNavii® Mentor BT and BT Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is indicated for singlepatient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-thecounter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The system can also set the pre-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked. A Bluetooth unit for data transfer has been added to the subject devices in addition to NFC and USB cable communication features. The following modifications were made on the subject device from the predicate device (K132929). - 1) The addition of Bluetooth for wireless transmission of data to mobile device or PC, and which comprises the following modifications: - i. Changed printed circuit board (PCB) layout. - ii. Added Bluetooth module to PCB. - iii. Added and deleted electronic components to support the Bluetooth Module. - iv. Deleted USB communication circuit. - Changed Firmware. V. - Added Bluetooth icon to display. vi. - Extended automatic meter shutoff times to allow enough time for data transfer via Bluetooth. vii. - 2) Memory capacity for stored glucose test results decreased from 300 to 100 records. - 3) The trade name of the systems has changed from SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System and SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System to SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System. - 4) The trade name of the test strips has changed from SD GlucoNavii® Mentor NFC Blood Glucose Test Strips and SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips to SD GlucoNavii® Mentor BT Blood Glucose Test Strips and SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips. - 5) Labeling was modified to reflect the changes to the device.
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    K Number
    K151265
    Device Name
    SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
    Manufacturer
    SD BIOSENSOR
    Date Cleared
    2015-11-24

    (195 days)

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

    SD BIOSENSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Blood Glucose Test Strips are for use with SD Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm and venous whole blood. SD GlucoNavii® Control Solution is intended for Quality Control of the SD GlucoNFC Multi Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.
    Device Description
    SD GlucoNFC Blood Glucose Monitoring System and GlucoNFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting (prescription; POC), in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. SD GlucoNFC Blood Glucose Monitoring System includes: - SD GlucoNFC Blood Glucose Meter - SD GlucoNFC Blood Glucose Test Strips - SD Glucose Check Strip - SD GlucoNavii® Control Solution – Level 2 - Lancet - Lancing device (with a white cap for fingertip testing and a clear cap for Alternative Site Testing) - User Instruction Guide - Test Strip Package Insert - Control Solution Package Insert SD GlucoNFC Multi Blood Glucose Monitoring System includes - SD GlucoNFC Multi Blood Glucose Meter - SD GlucoNFC Multi Blood Glucose Test Strips - SD Glucose Check Strip - SD GlucoNavii® Control Solution Level 2 - User Instruction Guide - Test Strip Package Insert - Control Solution Package Insert A drop of blood sample works with Glucose dehydrogenase (GDH) and potassium ferrocyanide in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: non-meal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL units. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
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    K Number
    K140827
    Device Name
    SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
    Manufacturer
    SD Biosensor, Inc.
    Date Cleared
    2015-09-30

    (547 days)

    Product Code
    LCP, JJE, JJX
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SD Biosensor, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control materials for the SD A1cCare System.
    Device Description
    The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (HbA1c) levels in fresh capillary or venous whole blood samples. It is intended for professional use. The SD HbA1c Control Set is intended for use as quality control materials for the SD A1cCare System. The SD A1cCare System include the analyzer, analyzer check strip, DC power adapter, immunoassay test panels, lot-specific calibration code chips, and control set.
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    K Number
    K132929
    Device Name
    SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SD BIOSENSOR, INC.
    Date Cleared
    2015-08-05

    (687 days)

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

    SD BIOSENSOR, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication. SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
    Device Description
    SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes: - SD GlucoNavii® Mentor NFC Blood Glucose Meter - SD GlucoNavii® Mentor NFC Blood Glucose Test Strips - SD Glucose Check Strip - SD Glucose Control Solution - Level M - 3V Battery Type CR2032 - User Instruction Guide - Quick Guide - Test Strip Package Insert - Control Solution Package Insert - Carrying Case - Lancing Device, Lancet SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes: - SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter - SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips - SD Glucose Check Strip - SD Glucose Control Solution Level M - 3V Battery Type CR2032 - User Instruction Guide - Quick Guide - Test Strip Package Insert - Control Solution Package Insert - Carrying Case Optional software accessory - GlucoNavii® DMS - GlucoNavii® A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
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    K Number
    K123517
    Device Name
    GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SD BIOSENSOR
    Date Cleared
    2014-01-17

    (429 days)

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

    SD BIOSENSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SD GlucoMentor Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The SD GlucoMentor Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoMentor Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The SD GlucoMentor Test Strips are for use with the SD GlucoMentor Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoMentor multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The SD GlucoMentor multi Blood Glucose Test Strips are for use with the SD GlucoMentor multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
    Device Description
    SD GlucoMentor™ blood glucose system is an Rx/OTC blood glucose monitoring system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. SD GlucoMentor™ blood glucose monitoring system is comprised of the following. - SD GlucoMentor"M blood glucose meter - - SD GlucoMentor™ blood glucose test strip - - -SD Glucose control solution - -SD Glucose check strip A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current. The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning. date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
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