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The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-300 Blood Glucose Monitoring System 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 GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-301 Blood Glucose Monitoring System 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 GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-302 Blood Glucose Monitoring System 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 GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-303 Blood Glucose Monitoring System 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 GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-304 Blood Glucose Monitoring System 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 GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-305 Blood Glucose Monitoring System 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 GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-300 Professional 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 only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control. The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife AC-301 Professional 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 only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control. The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife AC-302 Professional 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 only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control. The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife AC-303 Professional 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 only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control. The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife AC-304 Professional 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 only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of dabetes control. The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife AC-305 Professional 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 only. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

GL GoodLife Series Blood Glucose Monitoring System consists of: (1) Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. GL GoodLife Series Professional Blood Glucose Monitoring System consists of: Glucose Meter (Model no.: AC-300, AC-301, AC-302, AC-303, AC-304, AC-305), (2) Glucose Test Strips (Model no.: AC) prior 510(k) clearance K113307, (3) Two levels of glucose control solutions (L1 and L2) may be purchased separately. prior 510(k) clearance K113307, (4) Check Strip, (5) Instruction for use. These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same.

The FIA Blood Glucose Monitoring System (G2) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The FIA Blood Glucose Monitoring System (G2) is intended to be used by a single patient and should not be shared. The FlA Blood Glucose Monitoring System (G2) 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 FIA Blood Glucose Monitoring System (G2) should not be used for the diagnosis of or screening of diabetes or for neonatal use. The FIA Blood Glucose Test Strips (G2) are for use with the FIA Blood Glucose Meter (G2) to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The FIA Glucose Control Solutions are for use with the FIA Blood Glucose Meter (G2) and FIA Blood Glucose Test Strips (G2) to check that the meter and test strips are working together properly and that the test is performing correctly.

FIA Blood Glucose Monitoring System (G2) consists of: (1) Glucose Meter (2)Glucose Test Strips (3)Two levels of glucose control solutions (L1 and L2) may be purchased separately. Glucose control solutions were previously cleared under K032985. (4)Check Strip (5)Instruction for use FIA Blood Glucose Monitoring System (G2) is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use. The FIA Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the FIA Blood Glucose monitoring system (G2) and FIA Blood Glucose Test strips (G2). There are two levels of controls (L1 and L2). The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover. The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GoodLife CS-200 Blood Glucose Monitoring System 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 GoodLife CS-200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use. The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is intended for testing outside the body (in vitro diagnostic use) and intended for multiple-patient use in 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 lancing devices. The GoodLife CS-200 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes, nor for neonatal use. The GoodLife KP Professional Blood Glucose Test Strip is for use with the GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in venous or arterial whole blood or fresh capillary whole blood drawn from the fingertips

GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professional Blood Glucose Monitoring System consist of: - (1) Glucose Meter - (2) Glucose Test Strips - (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985. - (4) Check Strip - (5) Instruction for use [Test Principle] The GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use. [Control Solution] The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the GoodLife CS-200 & GoodLife CS-200 Professional Blood Glucose Monitoring System and GoodLife KP & GoodLife KP Professional Blood Glucose Test strips. There are two levels of controls (Levels 1, 2). [Check Strip] The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover. [Device Calibration] The device is calibrated by Digital Code Strip. While inserting the Digital Code Strip into the coding slot, the meter will turn on automatically and complete the coding. The meter will apply formula including this parameter of code to calculate the glucose value.

The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by health care professionals in a clinical setting: The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The PRECICHEK KP Blood Glucose Test Strip is for use with the PRECICHEK NS-101 POCT Professional Blood Glucose Meter to quantitatively measure glucose in fresh capillary drawn from the fingertips, venous and arterial whole blood samples. The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips to check that the meter and test strips are working together properly and that the test is performing correctly.

PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System consists of: - (1) Glucose Meter - (2) Glucose Test Strips - (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985. - (4) Check Strip - (5) Instruction for use [Test Principle] The PRECICHEK NS-101 POCT Professional Blood Glucose Monitoring System is electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use. [Control Solution] The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals to assess the performance of the PRECICHEK NS-101 POCT Professional Blood Glucose monitoring system and the PRECICHECK KP Blood Glucose Test strips. There are two levels of controls (Levels 1,2). [Check Strip] The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover. [Device Calibration] The device is calibrated by implicit coding process. The code number is the last two digits of the strip lot number. The user should input the strip lot number into the memory of the meter before use. While performing the blood glucose test, the strip lot number printed on the vial label is scanned to match the one in the memory. The meter will apply formula including this parameter to calculate the glucose value.

The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The PRECICHEK Cloudia Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The PRECICHEK Cloudia Blood Glucose Monitoring System 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 PRECICHEK Cloudia Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The PRECICHEK ACH Blood Glucose Test Strips are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The PRECICHEK Glucose Control Solutions are for use with the PRECICHEK Cloudia Blood Glucose Monitoring System and PRECICHEK ACH Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

PRECICHEK Cloudia Blood Glucose Monitoring System consists of: - (1)Glucose Meter - (2)Glucose Test Strips - (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985. - (4)Check Strip - (5)Instruction for use [Test Principle] PRECICHEK Cloudia Blood Glucose Monitoring System is an electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use. [Control Solution] The PRECICHEK Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) assessing the performance of the PRECICHEK Cloudia Blood Glucose monitoring system and PRECICHEK ACH Blood Glucose Test strips. There are two levels of controls (Levels 1,2). [Check Strip] The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover. [Device Calibration] The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

For single use- GoodLife AC-300 Blood Glucose Monitoring System The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-300 Blood Glucose Monitoring System 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 GoodLife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-301 Blood Glucose Monitoring System The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-301 Blood Glucose Monitoring System 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 GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-302 Blood Glucose Monitoring System The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-302 Blood Glucose Monitoring System 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 GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-303 Blood Glucose Monitoring System The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-303 Blood Glucose Monitoring System 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 GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-304 Blood Glucose Monitoring System The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-304 Blood Glucose Monitoring System 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 GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-305 Blood Glucose Monitoring System The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-305 Blood Glucose Monitoring System 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 GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-305 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. For multiple use- GoodLife AC-300 Professional Blood Glucose Monitoring System The GoodLife AC-300 Professional 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 only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-301 Professional Blood Glucose Monitoring System The GoodLife AC-301 Professional 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 only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-302 Professional Blood Glucose Monitoring System The GoodLife AC-302 Professional 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 only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-303 Professional Blood Glucose Monitoring System The GoodLife AC-303 Professional 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 only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-303 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-304 Professional Blood Glucose Monitoring System The GoodLife AC-304 Professional 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 only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. GoodLife AC-305 Professional Blood Glucose Monitoring System The GoodLife AC-305 Professional 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 only. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting. The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-305 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices. The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

GoodLife AC-300~305 Blood Glucose Monitoring System and GoodLife AC-300~305 Professional Blood Glucose Monitoring System consist of: (1)Glucose Meter (2)Glucose Test Strips (3) Two levels of glucose control solutions (Level I and Level II) may be purchased separately. Glucose control solutions were previously cleared under K032985. (4)Check Strip (5)Instruction for use These models have the same intended use and technological characteristics except the housing of the meter. Although the different shapes of housing, the materials are the same. [Test Principle] GoodLife AC-300~305 Blood Glucose Monitoring System and GoodLife AC - 300~305 Professional Blood Glucose Monitoring System are electrochemical biosensor system that measures the amount of electric current produced then displays the result as a blood glucose level on the LCD monitor. When the blood is drawn into the blood reaction zone of the test strip, the glucose in the blood sample mixes with a special chemical in the test strip, which produces a small electric current. The reaction current is proportional to the amount of glucose in the blood. The result is displayed on the LCD monitor and automatically stored in the meter for future use. [Control Solution] The GoodLife Glucose control solution is intended for in vitro diagnostic use (i.e. for external use only) to assess the performance of the GoodLife AC-300~305 with GoodLife AC Blood Glucose Test strips or AC-300~305 Professional Blood Glucose monitoring system with AC Professional Blood Glucose Test strips. There are two levels of controls (Levels 1,2). [Check Strip] The Check Strip can be used to check that the meter is operating properly. It is composed of PCB, resistor, top cover and bottom cover. [Device Calibration] The device is calibrated by implicit coding process. While inserting the test strip into strip slot to perform the blood glucose test, the coding procedure is complete. The meter will apply formula including this parameter of code to calculate the glucose value.

The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, producing ferrocyanide. Potassium ferrocyanide is produced in proportion to the glucose concentration of the blood sample. Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.

For the quantitative measurement of glucose levels in human whole blood by people with diabetes at home and by health care workers in a professional setting.

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