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The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.

Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.

The Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Comfort Curve test strips are designed for convenient, confident, and accurate testing of blood glucose in whole blood samples.

The provided text is a 510(k) summary for the Accu-Chek® Comfort Curve™ Test Strip. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain details about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory approval and comparison to a predicate device rather than performance study results.

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