Search Results

The ADVOCATE DUO 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".

Not Found

I am sorry, but without a detailed study report, I cannot provide the specific acceptance criteria, device performance, and study details that you requested. The provided text is a 510(k) clearance letter from the FDA, which confirms that the ADVOCATE DUO Blood Glucose plus Blood Pressure Monitoring System is substantially equivalent to legally marketed predicate devices.

The letter does not include:

• A table of acceptance criteria or detailed device performance metrics.
• Information on sample sizes, data provenance, or expert qualifications for ground truth.
• Details on adjudication methods or multi-reader multi-case studies.
• Information on standalone algorithm performance or the type of ground truth used.
• Sample sizes or ground truth establishment methods for the training set.

The letter primarily focuses on the device's intended use and regulatory classification. To obtain the information you're looking for, you would typically need access to the full 510(k) submission or a separate study report for the device.

Ask a specific question about this device