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The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

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This document is a 510(k) clearance letter from the FDA for the Avie A1C Test System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria or a study proving that the device meets such criteria.

The letter primarily focuses on:

• Confirming the device's substantial equivalence.
• Stating its regulatory classification (Class II).
• Outlining general controls and other FDA regulations the manufacturer must comply with.
• Providing contact information for various FDA offices.
• Including an "Indications for Use" statement for the device.

Therefore, based solely on the provided text, I cannot answer the requested questions about acceptance criteria and the study proving the device meets those criteria.

The requested information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) would typically be found in the detailed premarket notification (510(k) submission) itself, or in supporting performance study reports, not in the final clearance letter.

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