(71 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.
Liquid Glucose (Hexokinase) Reagent Set
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Liquid Glucose (Hexokinase) Reagent Set, which primarily details the regulatory approval of the device based on substantial equivalence to a predicate device. It does not include details about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.
§ 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.