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The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

The Elecsys® Cortisol CalCheck is a lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

This document is a 510(k) premarket notification for the Elecsys® Cortisol CalCheck, a quality control material. It describes the device's indications for use, its substantial equivalence to a predicate device, and some performance characteristics. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria vs. performance, sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth.

Therefore, I cannot fulfill the request as the detailed information about acceptance criteria, study design, and performance metrics are not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

If this were a study report, the typical information would include:

1. A table of acceptance criteria and the reported device performance: This would list quantitative thresholds (e.g., accuracy > 95%, CV

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