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The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for neonates or for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or venous whole blood.

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This document is an FDA 510(k) premarket notification acceptance letter for blood glucose monitoring systems. It does not contain information about the acceptance criteria or a study proving device performance. The sections provided focus on regulatory approval, indications for use, and administrative information related to the FDA submission.

Therefore, I cannot provide the requested information based on the given text.

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The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose(sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. Alternative site testing can only be performed during steady-state blood times (when glucose is not changing rapidly). The TRUE METRIX Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

The TRUE METRIX PROTM Professional Monitoring Blood Glucose System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions. The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

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The provided text is a 510(k) clearance letter from the FDA for the TRUE METRIX Self Monitoring Blood Glucose System and TRUE METRIX PRO Professional Monitoring Blood Glucose System. It primarily outlines the regulatory status and indications for use of the devices.

Crucially, this document does NOT contain a detailed report of acceptance criteria, device performance, study design, or any of the specific information requested in your prompt regarding sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The letter confirms that the devices are substantially equivalent to legally marketed predicate devices, meaning they have demonstrated similar performance and safety characteristics. However, the actual data supporting this equivalency, including specific performance metrics and study details, are not included in this FDA clearance letter. Such information would typically be found in the manufacturer's 510(k) submission itself, which is a much more extensive technical document.

Therefore, I cannot provide the requested table and study details based solely on the provided input.

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The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples. drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not be shared.

The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX™ Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).

The TRUE METRIX Test Strips are for use with the TRUE METRIX™ Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Test Strips to check that the meter and the test strip are working together properly and that the test is performing correctly.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions.

The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.

The TRUE METRIX Control Solution is for use with the TRUE METRIX PRO Professional Monitoring Meter and TRUE METRIX PRO Test Strips to check that the meter and test strip are working together properly and that the test is performing correctly.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the TRUE METRIX™ Self Monitoring Blood Glucose System and TRUE METRIX PRO™ Professional Monitoring Blood Glucose System. While it states that the device is substantially equivalent to legally marketed predicate devices, it does not contain the detailed acceptance criteria or a study summary proving the device meets those criteria.

The provided text primarily focuses on:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and general controls.
• Instructions for compliance with FDA regulations.
• Indications for Use for both the self-monitoring and professional monitoring systems, including what they measure, who they are for, and limitations.

Therefore, I cannot extract the specific information requested regarding acceptance criteria and a study proving their fulfillment from this document. Such information would typically be found in the manufacturer's submission to the FDA, which is not included here.

Ask a specific question about this device