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The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Connect 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 ACCU-CHEK Aviva Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For in vitro diagnostic use

The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability.

The provided text describes the ACCU-CHEK Aviva Connect Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with all the requested information for acceptance criteria and device performance.

Based on the available information, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions "Precision: For response targets

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