(450 days)
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):
| Acceptance Criteria (EN ISO 15197:2013) | Reported Device Performance (VivaChek™ Ino) |
|---|---|
| **For glucose concentrations |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.