(155 days)
The FORA TD-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 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 upper-arm, 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 FORA TD-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
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This document is a 510(k) premarket notification from the FDA for a blood glucose monitoring system. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details the device's indications for use: quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, upper-arm, calf, thigh). It's intended for healthcare professionals and people with diabetes at home, but not for diagnosis, screening, or use on neonates. Alternative site testing is only for steady-state blood glucose conditions.
To answer your request, I would need a different document, specifically one that includes the clinical study report or a summary of performance data against predefined acceptance criteria for the FORA TD-4251, U-Right TD-4252, and U-Right TD-4254 Blood Glucose Monitoring Systems. This document only provides the FDA's regulatory clearance.
§ 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.