(81 days)
The Accu-Chek Complete System is intended for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
The Accu-Chek Complete Meter is an invitro device designed for measuring the concentrations of glucose in whole blood which is applied to Accu-Chek Advantage or Accu-Chek Advantage H Test Strips.
The provided 510(k) summary (K973662) for the Accu-Chek Complete Meter does not contain information about acceptance criteria or a study that proves the device meets those criteria.
This document primarily focuses on establishing substantial equivalence to a predicate device (Accu-Chek Advantage System) by comparing their intended use, operating principles, and various features. It lists similarities and differences between the new device and the predicate but does not present performance data or acceptance criteria for the Accu-Chek Complete Meter itself.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study results based on the provided text. The document is a 510(k) summary, which often focuses on comparative aspects rather than detailed performance study reports.
§ 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.