(27 days)
The U-RIGHT TD-4247 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 U-RIGHT TD-4247 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The U-RIGHT TD-4247 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
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The provided text is a 510(k) premarket notification summary for the U-RIGHT TD-4247 Blood Glucose Monitoring System. It describes the device's intended use and the FDA's determination of substantial equivalence to a predicate device. However, it does not contain the specific details about acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text. The document is primarily a regulatory approval letter.
To fully answer your request, you would need access to the actual 510(k) submission document or the design validation reports for the U-RIGHT TD-4247 Blood Glucose Monitoring System, which would typically contain:
- A table of acceptance criteria (e.g., accuracy standards like ISO 15197 for blood glucose meters).
- Reported device performance against those criteria.
- Details about the clinical studies (sample size, data provenance, ground truth establishment, etc.).
§ 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.