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The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.

The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay measures hemoglobin A1c in human anticoagulated whole blood and hemolysate. The assay consists of three reagents (R1, R2, and Pretreatment Solution), which are liquid and ready to use.

The assay offers both an automated and a manual application. The automated application (A1c_E) lyses the anticoagulated whole blood specimen on the system for the automated application (A1c E). Samples may also be lysed manually using the ADVIA® Chemistry A1c_E Pretreatment Solution to obtain hemolysate for the manual application (A1c_EM). The two applications yield the same results.

The provided document is a 510(k) Summary for a medical device called the ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) Assay. This document describes a submission seeking FDA clearance for a modification to an existing device, specifically to extend the low end of the analytical measuring range of total hemoglobin (tHb).

However, the document does not contain the detailed study results, acceptance criteria tables with performance data, information on sample sizes for test and training sets, expert qualifications, or adjudication methods that would be typically found in a comprehensive study report proving a device meets acceptance criteria.

The 510(k) Summary states that "Performance data were needed to evaluate the change" and "The verification study of linearity was done in accordance with the CLSI standard recognized by the FDA. This study along with other verification activities demonstrate equivalent performance to the predicate and effective risk mitigations. The studies met pre-determined acceptance criteria." and "Testing verified all acceptance criteria were met."

While these statements confirm that studies were conducted and met acceptance criteria, the specific details requested in your prompt (e.g., the actual table of acceptance criteria vs. performance, sample sizes, expert involvement, etc.) are not present in this summary document.

Therefore, I cannot provide the requested information from this document. To answer your prompt, I would need a more detailed study report or clinical trial summary that includes the actual performance data and study design specifics.

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