(96 days)
The intended use of the AccuBase Arc Test Kit is for the determination of the relative percent (%) A16 (glycohemoglobin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method.
The AccuBase A1c Test Kit will be available to diabetes patients through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitoring the average glucose ooncentration in the body over the past 30, 60 or 90 days including; a calculated Mean Blood Glucose (MBG) determination based on the DCCT MBG equation (31.7 X Arc % - 66.1) == MBG mg/dl as part of an comprehensive individual diabetes outcomes management, glycemic status assessment and treatment program.
The AccuBasc Are Test Kit does not replace daily blood giucose monitoring.
While there are no known contraindications, it is well known that the existence of disturbed erythrocyte kinetics conditions (such as anemia) many result in a non-reportable test result duc to too few Red Blood cells per volume of sample. A list of potential confounding factors are reported on the test result at time of reporting. Keep out of reach of children and pets.
The intended reporting path of the AccuBase Ate test Kit test result include direct reporting to patients and/or a healthcare professional. Test results must be provided to a physician and/or healthcare professional for interpretation of specific A1e values and setting of specific target Air goals.
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This document is a 510(k) premarket notification approval letter for the Accu-Base A1c Test Kit. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text primarily focuses on regulatory approval, intended use, and general guidance for the applicant.
Therefore, I cannot extract the requested information from the provided document.
§ 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).