(64 days)
Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine. This "Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis andtreatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma". CFR862.1345
Not Found
This document is a 510(k) clearance letter from the FDA for a glucose test system. It does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.
The information provided is a regulatory approval, confirming that the device is substantially equivalent to a predicate device already on the market. It doesn't include performance metrics, study designs, or expert qualifications as requested in the prompt.
Therefore, I cannot answer the specific questions about acceptance criteria and study details based on the provided text.
§ 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.