(184 days)
The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma. The measurement of glycated serum proteins (Fructosamine) is useful for monitoring long-term control of diabetes. This application was developed for the Polymedco Poly-Chem analyzer.
The Polymedco Glyca-Direct™ Fructosamine Test is used for the quantitative determination of glycated proteins in serum and plasma.
This document is an FDA 510(k) clearance letter for "The Polymedco Glyca-Direct™ Fructosamine Test". It confirms the device's substantial equivalence to a predicate device but does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on regulatory approval rather than technical performance data.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the study design, acceptance criteria, and performance data.
§ 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).