(182 days)
The FORA TD-4244 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 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-4244 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA TD-4244 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
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The FDA 510(k) summary for the FORA TD-4244 Blood Glucose Monitoring System (K081715) provides some information about device performance but does not include a detailed study description with all the requested elements. However, I can extract the available information to construct a response.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to the ISO 15197:2003 standard, which defines accuracy criteria for blood glucose monitoring systems.
| Acceptance Criteria (ISO 15197:2003) | Reported Device Performance (FORA TD-4244) |
|---|---|
| **For Glucose Concentrations |
§ 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.