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The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

The AutoSure HT blood glucose meter and AutoSure HT test strips are used for testing of blood glucose. Contrex Plus 4 Glucose Control Solutions are used for quality control testing of the systems.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list numeric acceptance criteria for the device's accuracy in the way a typical performance study's pre-defined thresholds would. Instead, it states that "Results demonstrate substantial equivalence to the predicate system" and that "Clinical and non-clinical testing demonstrated that the AutoSure HT system performs in a substantially equivalent manner to that of the predicate."

However, we can infer the type of performance being evaluated. For Blood Glucose Monitoring Systems (BGMS), the primary performance metric related to accuracy is typically the comparison of results against a laboratory reference method. The document mentions "accuracy study" and "precision testing." While specific numerical criteria are not provided for the AutoSure HT, for BGMS devices, the FDA typically references ISO 15197 standards for accuracy, which often involve criteria like:

• X% of results within Y mg/dL of the reference method for glucose concentrations

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