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Diazyme Glycated Serum Protein Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients.

Diazyme Glycated Serum Protein Assay is used with a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples,

Diazyme Glycated Serum Protein Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.

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The provided text is a 510(k) clearance letter for the Diazyme Glycated Serum Protein Assay. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the study results that prove the device meets those criteria.

The information provided is largely administrative, focusing on the regulatory process rather than the technical performance study itself. Therefore, I cannot extract the requested information from this document.

To answer your request, a different document, such as a summary of safety and effectiveness, or the full 510(k) submission, would be needed. These documents typically contain the detailed performance studies, acceptance criteria, sample sizes, ground truth establishment, and other specifics you've asked for.

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