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Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Diazyme Direct Enzymatic HbA1c Assay, stating that the device is substantially equivalent to a legally marketed predicate device.

The information provided focuses on:

• The FDA's review and determination of substantial equivalence.
• Regulatory classification of the device.
• General controls provisions and other regulations the manufacturer must comply with.
• Contact information for further inquiries.
• The intended use of the device ("Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control.").

None of the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment are present in this document.

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