(156 days)
The EASYGLUCO™ Monitoring System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
The EASYGLUCO™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the EASYGLUCO™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
The provided text does not contain detailed information about acceptance criteria or specific study results for the EASYGLUCO™ device. The document is a 510(k) summary for an in vitro diagnostic device, primarily focusing on establishing substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The available information only describes the device, its intended use, and its substantial equivalence to other blood glucose monitoring systems. It does not include performance data or study design details.
§ 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.