(216 days)
The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC HemoglobinAlC Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.
The provided text describes the ATAC HemoglobinA1C Reagent Kit and studies performed to demonstrate its effectiveness. Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" for precision or method comparison in a pass/fail format. Instead, it presents the results of these studies. The "acceptance criteria" are implied by the performance statistics themselves, specifically that the results fall within generally accepted ranges for such assays or are comparable to the predicate device.
| Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | %CV values within acceptable limits for HbA1c assays. | Control 1: %CV (Within Run) = 3.38%, %CV (Total) = 4.74% |
| Control 2: %CV (Within Run) = 2.46%, %CV (Total) = 3.08% | ||
| Patient: %CV (Within Run) = 2.60%, %CV (Total) = 4.66% | ||
| Method Comparison | Strong linear correlation and agreement with a comparative method (TOSOH HPLC). Slope close to 1, intercept close to 0. | ATAC 8000 = 0.6367 + 0.9722 x Comparative Method |
| Calibration Stability | Total imprecision of %HemoglobinA1C recoveries over claimed period |
§ 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).