Diazyme Receives 510(k) FDA Approval for Enzymatic Glycated Serum Protein Assay Kit
Product News May 26, 2011
Diazyme Laboratories has announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Glycated Serum Protein (GSP, Glycated Albumin) Assay Kit.
Recent studies have shown that blood HbA1c levels alone may not accurately reflect serum glucose concentrations in all diabetic patients.
The difference between the actual measured HbA1c concentration and the predicted HbA1c from glycated serum protein test results is called the glycation gap.
Studies have demonstrated that the glycation gap information provided by measuring HbA1c and glycated albumin together offers improved diagnostic value by more reliably predicting complications of diabetes including coronary artery and kidney disease.
In addition, the glycated albumin test serves as an intermediate term indicator of average blood glucose for the past 2-3 weeks, which closes the existing information gap between daily blood glucose testing and the 2-3 month snapshot provided by HbA1c testing.
"Diazyme's new Glycated Serum Protein (Glycated Albumin) enzymatic assay provides additional diagnostic value to clinical practices in diabetes screening and management," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
Diazyme's Glycated Serum Protein (Glycated Albumin) enzymatic assay is a 2-part liquid stable reagent that can be used with various types of automated clinical chemistry analyzers. The enzymatic assay is more specific and accurate in comparison to the current non-enzymatic NBT-based fructosamine test.