(90 days)
Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbArt) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbAn). Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.
Not Found
The provided document is a 510(k) premarket notification letter for a Hemoglobin A1c Reagent Set, Calibrators, and Controls. It confirms that the device is substantially equivalent to a legally marketed predicate device.
However, the document does not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or reader studies. It is a regulatory clearance letter, not a scientific study report.
Therefore, I cannot provide the requested information from the given text.
§ 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).