(292 days)
The TD-3252 Blood Glucose plus Blood pressure 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. The alternative site testing in this system can be used only during steady-state blood , glucose conditions. This system is not intended for use on neonates.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".
This system offers either cable or wireless communication function which is able to transmit the test result to other devices, such as PC or data receiver.
This monitor has some speaking function but is not intended for use by the visually impaired.
Not Found
The provided text is related to the FDA's 510(k) clearance for the TD-3252 Blood Glucose plus Blood Pressure Monitoring System. It describes the indications for use but does not contain information about the acceptance criteria or the specific study details that prove the device meets these criteria.
Therefore, I cannot fulfill your request for the comprehensive table and study details as the necessary information is not present in the provided document.
To answer your request, I would need a document that describes:
- Specific performance metrics (e.g., accuracy ranges for glucose and blood pressure measurements).
- The methodology of a clinical study conducted to evaluate these metrics.
- Details about the test and training sets, including sample sizes, demographics, and ground truth establishment.
- Information on expert involvement and adjudication methods.
§ 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.