(387 days)
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.