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The GlucoDr™ auto blood glucose monitoring system is intended for in vitro diagnostic use (i.e., for external use only) for quantitative measurement of glucose in venous, arterial and capillary whole blood. Testing sites include traditional fingertip site along with palm, upper arm, forearm, thigh, and calf.

The GlucoDr" auto blood glucose monitoring system may be used by healthcare professionals or for self testing by diabetic lay users in the mellitus at home as aid in monitoring the effectiveness of diabetes control program.

The GlucoDr" auto blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The GlucoDr" auto control solution is for use with the GlucoDr™ auto test meters and strips as a quality control check to verify the accuracy of blood glucose test results.

The GlucoDr™ auto blood glucose monitoring system consists of GlucoDr™ auto Test Meter, GlucoDr™ auto Test strips and GlucoDr™ auto control solution.

The GlucoDr™ auto blood glucose monitoring system is based on measurement of electrical currents caused by the reaction of glucose with reagents on the gold electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents are proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ auto test meter.

The provided text is a 510(k) summary for the GlucoDr™ auto Blood Glucose Monitoring System. It describes the device's intended use, comparison to a predicate device, and conclusion of substantial equivalence. However, it does not contain the detailed study information requested, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any information about multi-reader multi-case studies or standalone performance.

Therefore, I cannot fulfill your request for this specific device based on the provided text. The document is a regulatory submission summary, not a detailed technical study report.

If you have a study report that contains this information, please provide it, and I will be happy to extract the requested details.

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