(197 days)
The GlucoDr™ Plus 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. Testing sites include traditional fingertip site along with palm, arm and thigh.
The GlucoDr "1" Plus system may be used by healthcare professionals or for self testing by diabetic lay users with diabetes mellitus at home as aid in monitoring the effectiveness of diabetes control program.
The GlucoDr The Plus system is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The GlucoDr™ Plus control solution is for use with the The GlucoDr™ Plus meters and strips as a quality control check to verify the accuracy of blood glucose test results.
The GlucoDr™ Plus system consists of GlucoDr™ Plus Test Meter, GlucoDr™ Plus Test strips and GlucoDr™ Plus control solution.
The GlucoDr™ Plus 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™ Plus test meter.
The provided text is a 510(k) summary for the GlucoDr™ Plus System. However, it does not contain the acceptance criteria or a detailed study description proving the device meets acceptance criteria. The document primarily focuses on establishing substantial equivalence to a predicate device, device description, and intended use.
Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary might refer to an internal report for validation studies, but the provided excerpts do not include that level of detail.
§ 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.