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The products encompassed by this request are intended for in-vitro diagnostics use and are intended for r ne products chooling and flushing the sample flow path of the equivalent OEM Analyzers. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path. The reagents are intended for use on equivalent OEM Instruments. The original equipment manufacturer (OEM) of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products, as shown in the packaging section of this submission.

Here's a breakdown of the acceptance criteria and the study details for the Mission Diagnostic Reagents, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format. However, the performance is demonstrated through precision coefficent of variation (%CV) and correlation (slope and R^2) against OEM reagents. The implicit acceptance criterion for this type of device (calibrators/reagents intended as direct replacements) would be that the Mission reagents perform comparably to the OEM reagents, demonstrating "substantial equivalence."

A reasonable interpretation of the acceptance criteria, based on the presented data, would be:

• Precision (%CV): Low %CV values, indicating good repeatability. While no specific threshold is given, the reported values are generally very low (often

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