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Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.

Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum. Preservative: Antimicrobial Agent.

The provided text is a 510(k) summary for the Bio-Rad Laboratories' Architect Progesterone MasterCheck. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It describes the intended use and technological characteristics of the device but does not contain information on acceptance criteria for a study proving device performance, nor details of a study with sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on the device's intended use, form, matrix, storage, analytes, and open vial claim, comparing these characteristics to a predicate device. It also includes the FDA's response letter indicating that the device has been found substantially equivalent.

Therefore, I cannot provide the requested information from the given text. The document does not describe a performance study with detailed acceptance criteria and results.

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