(244 days)
In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood
The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. The AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor. The AMD Home Health Glucose Monitor testing system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration. The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose Monitor. This device allows remote clinical review of test results obtained in the patient's home.
The provided text is a 510(k) summary for the AMD Home Health Monitoring System, a self-monitoring blood glucose device. It details the device description, intended use, predicate devices, and a comparison chart. However, it does not contain information about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment relevant to the requested questions. The document focuses on demonstrating substantial equivalence to predicate devices based on design and operational characteristics, not on presenting performance study data against pre-defined acceptance criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as this information is absent.
§ 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.