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The Elect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.

The Elect Blood Glucose Monitoring System comprises a glucose reagent test strip, a amperometric meter and a quality control solution. The user inserts a test strip in the Elect Meter and applies a small drop of blood from a fingerstick to the sample point on the strip. The meter measures the electrical current that is generated which is proportional to the concentration of glucose present in the blood sample. The blood glucose result is displayed in 20 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.

The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study. The text primarily describes the "Elect Blood Glucose Monitoring System," its intended use, and its equivalence to other devices, focusing on product description rather than clinical study results or validation.

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