(30 days)
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.
Not Found
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.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).