(33 days)
The Accu-Chek Advantage Module is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
The Accu-Chek Advantage Module is an in vitro device designed for measuring the concentration of glucose in whole blood, which is applied to the Accu-Chek Comfort Curve test strips. The test principle is: The enzyme glucose dehydrogenase converts the glucose in a blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator, hexacyanoferrate (II). The test strip employs the electrochemical principle of biamperometry. The meter applies a voltage between two identical electrodes, which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator. This generates a small current that is read by the meter.
The provided text is a 510(k) summary for the Accu-Chek Advantage Module, a device for measuring glucose in whole blood. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, study details (like sample size, data provenance, ground truth establishment), or comparative effectiveness studies (MRMC) with human readers.
Therefore, I cannot provide the requested information from the given text. The document is solely a premarket notification summary and does not include the detailed study results that would typically be part of a submission to demonstrate performance.
§ 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.