(163 days)
The quantitative determination of glucose in whole blood.
Blood Glucose Monitoring System ( Meter, Test Strips, Control Solutions )
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a blood glucose monitoring system, which confirms the device's substantial equivalence to a predicate device. It does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
§ 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.