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The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the FORA G90 / U-Right TD-4234 Blood Glucose Monitoring System, which states that the device is substantially equivalent to a legally marketed predicate device.

The document discusses:

• The FDA's review of the premarket notification.
• The device's classification and regulation details.
• General controls provisions and other regulatory requirements.
• The instructions for use and indications for the device.

It does not include any information about:

• Specific acceptance criteria (e.g., accuracy percentages, limits of agreement).
• A study's design, results, or comparison to acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details about establishing ground truth.
• Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

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