(23 days)
The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin in fresh capillary or venous whole blood samples. The test is for prescription home use by people with diabetes to monitor glycemic control.
Not Found
This is a 510(k) premarket notification for the A1cNow™ device, a glycosylated hemoglobin assay for prescription home use. There is no information in the provided text that describes the acceptance criteria, or a study that proves the device meets the acceptance criteria. The document is primarily a letter from the FDA confirming the device's substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information in the format requested.
§ 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).