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The FORA TD-3224 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, and is not intended for use on neonates. The alternative site testing in the system can be used only during steady-state blood glucose conditions.

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, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" ~ 7.75".

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Information regarding acceptance criteria and study details for the FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System, as requested, is not provided in the provided text.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain the detailed study results, acceptance criteria, or methodology of the performance evaluation for this specific device.

Therefore, I cannot extract the requested information from the given text.

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