(245 days)
Measurement of Glycohemoglobin in blood. In vitro diagnostic use only. NycoCard HbA1c is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.
Not Found
This document is an FDA 510(k) clearance letter for the NycoCard HbA1c Glycated Hemoglobin Assay. It specifies the intended use and regulatory classification but does not contain the acceptance criteria or a study describing the device's performance against those criteria.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based solely on the provided text. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, which implies that performance data was submitted and found acceptable by the FDA, but the details of that data and the specific acceptance criteria are not included here.
To answer your request, I would need access to the full 510(k) submission, which typically contains the performance data and the associated acceptance criteria.
§ 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).