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The Audit™ MicroCVTM ASO Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Anti-streptolysin O (ASO) analyte. The five levels demonstrate a linear relationship to each other for Anti-streptolysin O (ASO) analyte. It is intended to simulate human patient serum samples for purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin O (ASO). This product may be used as unassayed quality control material for Anti-streptolysin O (ASO) analyte.

The Audit™ MicroCV™ ASO Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Anti-streptolysin O (ASO). It is used to confirm the proper calibration, linear operating range, and reportable range of ASO. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.

The provided document is a 510(k) Summary for the Audit™ MicroCV™ ASO Linearity Set, a quality control material. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on the stability of the product (open vial stability and shelf life) as the primary performance data discussed, and uses this stability data, along with comparisons to a predicate device's characteristics, to support its claim of substantial equivalence.

Therefore, I cannot provide the requested table and study details based on the input document. The document states:

• "Stability studies have been performed to determine the shelf life for the Audit™ MicroCV™ ASO Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd."

This indicates that internal studies were conducted for stability, but no performance metrics are given to establish acceptance criteria for the device's primary function of demonstrating linearity or monitoring precision, nor are any studies described in detail.

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