Search Results

TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample. TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration value is reported in plasma equivalents and is displayed on meter screen.

RIGHTEST Blood Glucose Monitoring System Max Tel is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor the effectiveness of diabetes control. It 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 RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

RIGHTEST Blood glucose monitoring System Max Tel consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. RIGHTEST Blood Glucose Meter Max Tel, when used with the RIGHTEST Blood Glucose Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of RIGHTEST Blood Glucose Monitoring System Max Tel is verified by the RIGHTEST Control Solution GC700. The glucose measurement is achieved by using the amperometric detection meth test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD-glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use. The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately. The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter. The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.

The CONTOUR® NEXT GEN Blood Glucose Monitoring System consists of the CONTOUR® NEXT GEN meter, CONTOUR® NEXT blood glucose test strips and the CONTOUR® Diabetes app. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® NEXT GEN Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT GEN 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® NEXT GEN Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The system is intended for in vitro diagnostic use only. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood qlucose test strips, and the CONTOUR® Diabetes app. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips. The system is intended for in vitro diagnostic use only.

CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE Blood Glucose Meters have Bluetooth Low Energy technology built in so that the meters can communicate wirelessly to smart phones and tablets. The CONTOUR® NEXT GEN meter uses the CONTOUR® NEXT blood glucose test strips and CONTOUR® NEXT control solution and CONTOUR® PLUS BLUE meter uses CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution respectively. The meters can be connected to the CONTOUR® Diabetes app. Both the meters use two replaceable coin cell batteries. Both the meters' shape is a traditional oval form factor. The CONTOUR® NEXT GEN and CONTOUR® PLUS BLUE meters have smartLIGHT® and smartCOLOR® indicator features respectively to see if a glucose result is above, within, or below target range.

VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared. VivaChek™ Fad Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared. VivaChek™ Fad Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately. VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately. VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately. VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample. VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The ducose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately. The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose test strips and the Contour® Diabetes app. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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 in monitoring the effectiveness of a diabetes control program. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips. The system is intended for in vitro diagnostic use only.

CONTOUR® PLUS BLUE Blood Glucose Monitoring System is a blood glucose monitoring system with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System. It uses two replaceable coin cell batteries. The meter's shape is a traditional oval form factor and it includes an on-screen arrow that points to the color indicating if a glucose result is above, within, or below target range.

RIGHTEST Blood Glucose Monitoring System Max Tel is intended to the quantitative measurement of glucose (sugar) in fresh capillary whole drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. RIGHTEST Blood Glucose Monitoring System Max Tel is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to montor the effectiveness of diabetes control. It 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 RIGHTEST Blood Glucose Monitoring System Max Tel is comprised of the RIGHTEST Meter Max Tel and the RIGHTEST Blood Glucose Test Strip Max.

RIGHTEST Blood glucose monitoring System Max Tel consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device and Sterile Lancets. The RIGHTEST Blood Glucose Test Strip Max is the same as Test Strip Max cleared in K173638.The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. RIGHTEST Blood Glucose Meter Max Tel, when used with the RIGHTEST Blood Glucose Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of RIGHTEST Blood Glucose Monitoring System Max Tel is verified by the RIGHTEST Control Solution GC700. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD-glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. VivaChek™ Link Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek Link Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. VivaChek Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.

The TRUENESS™ AIR Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ AIR Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ AIR Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates. The TRUENESS™ AIR Blood Glucose Monitoring System is comprised of the TRUENESS™ AIR blood glucose meter and the TRUENESS™ blood glucose test strip. The TRUENESS™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of their diabetes control program. The TRUENESS™ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is for in vitro diagnostic use only. The TRUENESS™ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates. The TRUENESS™ Blood Glucose Monitoring System is comprised of the TRUENESS™ blood glucose meter and the TRUENESS™ blood glucose test strip.

The TRUENESS Blood Glucose Monitoring System and TRUENESS AIR Blood Glucose Monitoring System mainly consist of two parts as below: (1) TRUENESS Blood Glucose Meter or TRUENESS AIR Blood Glucose Meter (With Bluetooth function) (2) TRUENESS Blood Glucose Test Strip A glucose test is based on measurement of electrical current caused by the reaction of glucose with flavin adenine dinucleotide (FAD) glucose dehydrogenase on the electrode of the test strip. The blood or control solution sample is drawn into the tip of the TRUENESS Blood Glucose Test Strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The magnitude of the resultant current is proportional to the concentration of glucose in the blood and is converted to a glucose concentration. The glucose concentration is displayed on the meter display for the user.