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The Prodigy Preferred Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Prodigy Preferred 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 to monitor the effectiveness of diabetes control. The Prodigy Preferred Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.

The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and Prodigy No Coding Test Strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Prodigy Preferred Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Preferred Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.

Here's a summary of the acceptance criteria and study information for the Prodigy® Preferred Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For many of the tests, the acceptance criterion specifically states "met the acceptance criteria" or "less than X" while also reporting the actual performance as "less than X" or "within acceptance criteria," implying that the stated performance is the acceptance criterion itself, or that the performance achieved the desired threshold.

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