(73 days)
The TRUE METRIX AIR 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. TRUE METRIX AIR Self-Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX AIR 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 AIR 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 Self-Monitoring Test Strips are for use with the TRUE METRIX AIR Self-Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX AIR 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 AIR PRO Professional 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 AIR PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used 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 AIR PRO Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm or venous whole blood.
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This document is an FDA 510(k) clearance letter for the TRUE METRIX AIR Self-monitoring Blood Glucose System and the TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study methodologies commonly found in a clinical study report or a detailed 510(k) submission.
Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on the regulatory clearance for the device, including:
- Device Name: TRUE METRIX AIR Self-monitoring Blood Glucose System and TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System
- Regulation Number and Name: 21 CFR 862.1345, Glucose test system
- Regulatory Class: II
- Product Code: NBW
- Indications for Use: Quantitatively measuring glucose in fresh capillary whole blood (and venous whole blood for the PRO system) for diabetes monitoring, intended for self-testing or professional healthcare settings. It explicitly states it should not be used for diagnosis, screening, or neonate use.
- Type of Use: Over-The-Counter for the standard system; Prescription Use and Over-The-Counter Use for the PRO system.
To answer your questions, I would need a clinical study report, a summary of safety and effectiveness data, or a more detailed section of the 510(k) submission that describes the validation studies.
§ 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.