Search Results

VivaChek™ Ino Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Smart Blood Glucose Meter (VGM04) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino 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 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™ Ino Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sync Blood Glucose Meter (VGM05) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino 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™ Ino Sound Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Blood Glucose Meter (VGM09) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound 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 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™ Ino Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Plus Blood Glucose Meter (VGM22) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™M Ino 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™ Ino Sound Simple Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Simple Blood Glucose Meter (VGM26) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Simple 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™ Ino Sound Bright Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Sound Bright Blood Glucose Meter (VGM27) and the VivaChek™ Ino Blood Glucose Test Strips (VGS01). The VivaChek™ Ino Sound Bright 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™ Ino Smart Blood Glucose Monitoring System (Model: VGM04) 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 enzyme 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™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model:VGM09), VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26), VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) are 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 enzyme 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™ Ino Smart Blood Glucose Monitoring System (Model: VGM04), VivaChek™ Ino Sync Blood Glucose Monitoring System (Model: VGM05), VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09) and VivaChek™ Ino Plus Blood Glucose Monitoring System (Model:VGM22) contain Bluetooth, the devices comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Please refer to the FCC PART 15.247 BLE Test Reports #1803WSU007-U1 for VGM09 and VGM22 systems, and #1803WSU007-U2 for VGM04 and VGM05 systems.

VivaChek™ Ino Sound Blood Glucose Monitoring System (Model: VGM09), VivaChek™ Ino Sound Simple Blood Glucose Monitoring System (Model: VGM26)and VivaChek™ Ino Sound Bright Blood Glucose Monitoring System (Model: VGM27) contain talking functionality, refer to Talking Feature Validation Protocols and Reports, and Meter Robustness Study Protocol and Report.

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the VivaChek Ino Blood Glucose Monitoring Systems.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various laboratory and clinical tests conducted. While it doesn't present a single consolidated table of acceptance criteria vs. specific quantitative performance for all metrics, it clearly states "Conclusion | Pass" for all listed tests, indicating that the devices met their respective acceptance criteria based on the referenced guidance documents (primarily FDA SMBG Guidance and ISO 15197:2015).

For system accuracy, the key acceptance criteria for glucose monitoring systems are generally based on ISO 15197. The document indirectly confirms adherence to these by stating the "User Evaluation" and "User Evaluation-Accuracy at Extreme Glucose Values" passed per "FDA SMBG Guidance". The FDA SMBG Guidance often references or aligns with ISO 15197. Without explicit performance data tabled, we infer that the devices met the performance criteria outlined in these guidance documents.

Implied Acceptance Criteria (based on FDA SMBG Guidance and ISO 15197:2015, which the device passed):

Ask a specific question about this device

VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.

The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.

The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) 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 enzyme 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 meter is calibrated to display plasma-like concentration results.

All 3 levels control solution consists of glucose in water with buffers and a preservative, and a dye. The device is formulated to provide low, normal and high ducose values representative of low, normal and high blood glucose values in subjects. The active ingredient, glucose, is the same analyte measured in blood specimens by the relevant blood glucose test systems. The proprietary characteristics of the solution have been modified to mimic the measurement of blood specimens with this non - biological, non - toxic, aqueous solution. The product does not contain red blood cells, and so, cannot be used to assess hematocrit effects on glucose measurement. The solution has a red color to enhance its visibility.

The VivaChek™ Ino Blood Glucose Monitoring System underwent various tests to demonstrate its accuracy and establish substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text references compliance with EN ISO 15197:2013, which specifies accuracy requirements for blood glucose monitoring systems. While the exact performance metrics from the VivaChek Ino study are not explicitly listed in a direct comparison table within this document, the overall conclusion states that the device "meets the accuracy requirements per EN ISO 15197."

For blood glucose monitoring systems, EN ISO 15197:2013 typically sets the following accuracy criteria against a laboratory reference method (e.g., YSI):

Ask a specific question about this device