(23 days)
The Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The Clever Chek TD-4237 / AudioChek Blood Glucose Monitoring System contain a speaking functionality which provides step by step instructions to aid visually impaired persons.
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This document is a 510(k) premarket notification decision letter from the FDA for the Clever Chek TD-4237 I AudioChek Blood Glucose Monitoring System. It mainly focuses on the regulatory approval, and does not contain the detailed study information required to answer your questions.
Specifically, the document states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This means the FDA found the device to be similar enough to previously approved devices that it doesn't require a new, extensive clinical trial. The letter refers to "indications for use stated in the enclosure" but the enclosure itself (which would contain detailed performance data) is not provided in the input text.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on the detailed technical data and study methodology that would typically be found in an in-depth clinical study report.
§ 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.