(27 days)
The Smartest Persona Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
The Smartest Persona Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
The provided text is a 510(k) summary for the Smartest Persona Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and the conclusion that it is substantially equivalent. However, it does not include detailed information regarding acceptance criteria, specific performance study results, sample sizes for test or training sets, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot populate the requested information from the provided text. The document states that "Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements," but it does not elaborate on what those requirements or the results of those activities were.
§ 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.