(93 days)
The self-testing EasyMate Blood Glucose Monitoring System is indicated for use by healthcare professionals and persons with diabetes to measure glucose values in capillary, finger stick whole blood. Frequent monitoring of whole blood glucose is an adjunct to the care of persons with diabetes.
Not Found
The provided document is an FDA 510(k) clearance letter for the EasyMate Blood Glucose Monitoring System, not a study report. Therefore, it does not contain the detailed information required to answer your questions about acceptance criteria and the study proving the device meets them.
The letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, indicating it has met the regulatory requirements for market clearance. However, it does not describe the specific performance studies, acceptance criteria, or their results in detail.
To provide the information you requested, an FDA submission document (e.g., the 510(k) application itself) or a separate clinical study report would be necessary.
§ 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.