(83 days)
The EasyRA HbA1c Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood using the EasyRA clinical chemistry analyzer. HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
The EasyCAL HbA1c calibrator is used for calibrating the HbA1c on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbA1c Reagent. The HbA1c calibrator is used to establish points of reference that are used in the determination of values in the measurement of HbA1c in human whole blood.
The EasyQC HbA1c QC Materials are intended to use as quality control material for the HbA1c immunoturbidimetric assay, using EasyRA HbA1c Reagent and EasyCAL HbA1c calibrator on the EasyRA clinical chemistry analyzer.
Not Found
This is a 510(k) clearance letter for the EasyRA HbA1c Reagent Kit, HbA1c Calibrator Kit, and HbA1c QC materials. The document indicates that these are in-vitro diagnostic devices intended for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood using the EasyRA clinical chemistry analyzer. HbA1c measurements are used for monitoring long-term blood glucose control in diabetic patients.
However, the provided document does not contain any information regarding acceptance criteria, study details (like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment) or reported device performance. The document is solely a formal letter from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided.
§ 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).