(43 days)
Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers.
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.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to JAS Diagnostics, Inc. regarding their Glucose Reagent. This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance, study design, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document confirms that the FDA determined the device to be "substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976," allowing it to be marketed, but it does not detail the technical performance studies.
§ 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.