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The On Call® Express Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.

The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).

The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

The On Call Express Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The On Call Express Pro Blood Glucose Monitoring System contains a blood glucose meter and On Call Express Pro blood glucose test strips. This is a no code meter. The On Call Express Pro Blood Glucose Monitoring System consists of the On Call Express Pro Blood Glucose Meter, On Call Express Pro Blood Glucose control solutions (Level 1 and Level 2), Carrying Case, User's Manual, Warranty Card and Logbook. Materials needed but not provided are the On Call Express Pro Blood Glucose Test strips and disposable, single use lancing devices.

Control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. The products are intended for use to verify the performance of the On Call Express Pro Blood Glucose Monitoring System

On Call Express Pro Blood Glucose Monitoring System has a data transfer function.

Data Port sends information to a computer via an optional data transfer cable. It allows users to view, analyze and print stored data in the meter. The data transfer cable is available for order as an optional add-on. The meter can transfer stored test results to a Windows-based personal computer (PC) using an optional data transfer cable and the On Call® Diabetes Management Software (K131469). The software has been validated for use with On Call Express meter (K132086) which is the exact same device as On Call Express Pro meter.

Here's a summary of the acceptance criteria and the study details for the On Call® Express Pro Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems are generally outlined in ISO 15197:2013. While the document doesn't explicitly state the acceptance criteria thresholds (e.g., specific percentages for each glucose range), it reports the device's performance against typical accuracy categories. The FDA guidance mentioned ("FDA Guidance for Industry In-Vitro Diagnostic Glucose Test System") would also refer to these standards.

Below is a combined table showing the reported device performance for both the Method Comparison Study (Healthcare Professionals) and the User Performance Study (Lay Persons). The implicit acceptance criteria are that the device performance meets or exceeds these reported percentages, aligning with regulatory standards for glucose meters.

Method Comparison Study (Healthcare Professionals)

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