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AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. The meter is a portable, battery-operated instrument.

The provided text describes the AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System, which states that it complies with ISO 15197:2003. This standard specifies the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the summary states compliance, it does not explicitly provide a table of acceptance criteria or reported device performance against specific targets from ISO 15197. Therefore, the following information is based on the general understanding of ISO 15197 for blood glucose meters, as the specific performance data is not detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

As specific performance data against ISO 15197:2003 criteria is not provided in the document, a general representation based on the standard's requirements for accuracy is used.

| Performance Characteristic | Acceptance Criteria (from ISO 15197:2003 for glucose values ≥ 4.2 mmol/L (75 mg/dL) and

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