(64 days)
The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Polymedco HbA1c Test, an in vitro diagnostic device. It does not contain any information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.
The letter primarily focuses on the substantial equivalence determination of the device to legally marketed predicate devices, which allows it to proceed to market. It outlines regulatory requirements and provides contact information for further inquiries.
Therefore, I cannot extract the requested information from the provided input. The document is a regulatory approval notice, not a performance study report.
§ 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).