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The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.

The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions.

The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.

TRUEbalance Blood Glucose System

This document is a 510(k) clearance letter for the TRUEbalance Blood Glucose System. It primarily addresses the FDA's determination of substantial equivalence, and therefore, does not contain the detailed information required to answer your prompt regarding acceptance criteria and a study proving device performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act."

The accompanying "Indication for Use" statement (page 2 of the document) describes the intended use of the device but offers no performance data or study details.

Therefore, based solely on the provided text, I cannot extract the information required to populate the table or answer the specific questions about the device's acceptance criteria and the study that proves performance.

To answer your prompt, I would need access to the full 510(k) submission or at least the performance study section of that submission.

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