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The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets. The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

For single patient use Easy Plus II Blood Glucose Monitoring System, Model 6276-S The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Easy Plus II Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Easy Plus II Test Strips are for use with the Easy Plus II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Control Solutions are for use with the Easy Plus II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly. Smartest Persona II Blood Glucose Monitoring System, Model 6276-S The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Smartest Persona II Test Strips are for use with the Smartest Persona II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Control Solutions are for use with the Smartest Persona II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly. For multiple patient use Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Easy Plus II Multi Test Strips are for use with the Easy Plus II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Multi Control Solutions are for use with the Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly. Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly). The Smartest Persona II Multi Test Strips are for use with the Smartest Persona II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Multi Control Solutions are for use with the Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.

The Easy Plus II Blood Glucose Monitoring System, Model 6276-5 (also applicable to: Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M; Smartest Persona II Blood Glucose Monitoring System, Model 6276-S; Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately. To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or screening for diabetes mellitus, nor for use in neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains an audible readout function that provides an audible message of test results for users. The SOLUSmobile Blood Glucose Management System uses cellular data transmission to send test results to a cloud server, Telemed-Gluconet. The SOLUSmobile Blood Glucose Test Strips are to be used with the SOLUSmobile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood from the finger and the forearm. These test strips are intended for use by a single patient with diabetes mellitus at home and should not be shared. The SOLUSmobile Control Solutions are for use with SOLUSMobile Meter and Test Strips to check that the meters and test strips are working together properly and that the test is performing correction. A control test that falls within the stated range indicates the user technique is appropriate and the test strip and meter are functioning properly.

The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose meter, test strips, control solutions, a lancing device, lancets, battery charger and charging cable, and instructions for use. To perform a test, a glucose test strip is inserted into the top of the monitor. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen. An embedded cellular communications module within the SOLUSmobile meter enables automatic wireless data transmission over the Wireless cellular network between the meter and a Central Data Repository (Cloud server). The test strips, control solutions, lancing device, and lancets are identical to previously cleared devices. The fundamental scientific technology of the SOLUSmobile except the device's communications capabilities remains unchanged from the legally marketed predicate device, SOLO V2 (K093764).

The Smartest™ Glucowise 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 or forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus. The Smartest™ Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the Smartest™ SuperCheck I Blood Glucose Monitoring System (K091815). The Smartest™ Glucowise Blood Glucose Monitoring System has done a cleaning and disinfection validation test to comply with "Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA" dated September, 30th, 2010. For single patient use Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 1 6267-S is intended to be used by a single person and should not be shared. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S 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 Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Smartest™ Glucowise Test Strips are for use with the Smartest™ Glucowise Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Control Solutions are for use with the Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S as a quality control check to verify that the meter and test strips are working together properly. For multiple patient use Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Smartest™ Glucowise MULTI Test Strips are for use with the Smartest™ Glucowise MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that the meter and test strips are working together properly.

The Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately. To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

The Easy Talk Blood Glucose Monitoring System, consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The Smartest Persona Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

The Smartest Persona Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood glucose test strips, control solutions, the lancing device, and lancets. The meter also comes with a speaking function that provides audible test results for users with low vision. The SuperCheck 1 Model 6268 allows the forearm to be used as an alternate site. User performance testing was conducted to support an over-the-counter indication.