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Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers

The Elecsys CalCheck T4 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

The provided text is a 510(k) summary for the "Elecsys® CalCheck™ T4," a calibration verification material. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader improvement with AI.

This document pertains to a calibration verification material, which is a control used to ensure the accuracy of an immunoassay analyzer. The "study" mentioned here refers to the comparison of this new calibration material to a predicate device, focusing on its intended use for calibration verification rather than clinical diagnostic performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device for a calibration verification product, not on clinical performance studies of a diagnostic algorithm or device where the questions posed would be relevant.

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