Search Results

ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.

The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. 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" to 7.75".

The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.

This monitor contains some speaking functions but is not intended for use by the visually impaired.

The kit of ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System consist of four main products: the monitor features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K041107), and the lancet device. These products have been designed and tested to work together as a system to produce accurate blood glucose test results.

The provided text does not contain detailed acceptance criteria and performance data for the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E. It primarily consists of a 510(k) summary indicating substantial equivalence to a predicate device based on similar operating principles, fundamental scientific technology, basic circuit design, materials, shelf life, and manufacturing process.

The document states that "Software verification and validation testing confirmed that the performance, safety and effectiveness of the ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System is equivalent to the predicate device." However, it does not present the specific acceptance criteria or the reported device performance from those tests.

Therefore, I cannot populate the requested table or provide specific details on sample sizes, ground truth establishment, expert qualifications, or study methodologies as this information is not present in the provided text.

The text does indicate:

• Type of Ground Truth Used (training and test set): Not explicitly stated, but for blood glucose, systems typically compare results against a laboratory reference method. For blood pressure, comparison is usually against a validated reference device (e.g., sphygmomanometer with auscultation).
• Sample Size for Training Set: Not mentioned.
• How the Ground Truth for the Training Set was Established: Not mentioned.

In summary, the provided document focuses on the regulatory submission for substantial equivalence rather than a detailed presentation of performance study results against specific acceptance criteria.

Ask a specific question about this device