(171 days)
The GlucoDr™ SuperSensor system is intended for in vitro diagnostic use (i. e., for external use only) for quantitative measurement of glucose in venous whole blood and capillary whole blood from the fingertip.
The GlucoDr™ SuperSensor system may be used by healthcare professionals or for self testing by diabetic lay users in the home.
The GlucoDr"M SuperSensor system is not intended for the diagnosis of or screening for diabetes mellitus.
The GlucoDr™ SuperSensor system is not intended for use on neonates.
The GlucoDr™ SuperSensor system consists of the GlucoDr™ SuperSensor Test Meter, GlucoDr™ SuperSensor Test strips and GlucoDr™ SuperSensor control solution. The GlucoDr™ SuperSensor system is based on measurement of electrical currents caused by the reaction of glucose with the regents on the glod electrode strip. Glucose in the sample reacts with glucose dehydrogenase and mediators. This reaction creates electrical currents. The subsequent electrical currents is proportional to the glucose concentration in the blood and converted to the equivalent glucose concentration by the algorithm programmed in the GlucoDr™ SuperSensor test meter.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The text provided is a 510(k) summary and related FDA correspondence for a medical device called the GlucoDr™ SuperSensor System, which primarily focuses on its substantial equivalence to a predicate device and its intended use. There are no details regarding specific performance metrics, test methodologies, sample sizes, or expert adjudication as requested in your prompt.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.