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The GlucoSure ADVANCE Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The GlucoSure ADVANCE Link Blood Glucose Monitoring System consists of the GlucoSure ADVANCE Link Blood Glucose Meter, GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution are purchased separately. The modified device of GlucoSure ADVANCE Link Blood Glucose Meter is derived from the existing device of BGM014 Blood Glucose Meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device. The blood glucose test strips and glucose control solution utilized in the GlucoSure ADVANCE Link Blood Glucose Monitoring System are the same as the BGM014 Blood Glucose Test Strips and Contrex Plus 5 Glucose Control Solution, previously cleared in k161299. The meter materials of GlucoSure ADVANCE Link Blood Glucose Meter are the same as the BGM014 Blood Glucose Meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in k161299.

The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It 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 diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It 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 diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

BGM039 brand of Blood Glucose Monitoring System is designed to have two variation models, BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring System is the models with all the changes implemented with exception to the addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose Monitoring System is implemented with all of the changes stated in the submission. The two meters use the same BGM039 Test Strip and Contrex Plus 4 Control Solution. This Premarket Notification (510(k)) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, K202885. BGM039 Blood Glucose Monitoring System and BGM039 Link Blood Glucose Monitoring System consists of the blood glucose meter and single use test strips. It is used for testing of blood glucose by self-testers at home.

The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips. The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution are purchased separately. The modified device of GlucoSure Link glucose meter is derived from the existing device of AutoSure Voice II meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device and removed the voice Feature. The glucose test strips and glucose control solution utilized in the GlucoSure Link Blood Glucose Monitoring System are the same as the AutoSure glucose test strips and Contrex Plus Glucose Control Solution, previously cleared in k102037. The meter materials of GlucoSure Link glucose meter are the same as the AutoSure Voice II meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in k150396.

MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips. The MTM301 Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MTM301 Blood Glucose and Ketone Monitoring System consists of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution (Level 1, Level 2), and MTM301 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution, and MTM301 ketone control solution are purchased separately. The glucose test strips utilized in the MTM301 Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips previously cleared in k170267 ; The ketone test strips are the same as the KET-1 Blood Ketone test strips, previously cleared in k182593.

GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips. The GAL-1A Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The GAL-1A Plus blood glucose monitoring system consists of the GAL-1A Plus meter and GAL-1A Test Strips. It is used for testing of blood glucose by self-testers at home.

MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips. The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately. MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured. The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in k170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in k182593.

GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use. The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The GlucoSure HT Plus blood glucose monitoring system consists of the GlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used for testing of blood glucose by self-testers at home.

KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.

The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 Ketone Control Solutions (Level 1 and Level 2). The system is for self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and KET-1 Ketone Control Solutions are purchased separately.

The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose.

The BGM014 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto diagnostic use), It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly. The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

The BGM014 blood glucose meter and BGM014 test strips are used for self-testing of blood glucose. The BGM014 Pro blood glucose meter and BGM014 Pro test strips are used for professional testing of blood glucose.