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VALIDATE® VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analyte: total 25 (OH) vitamin D (VIT D).

Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and study proving the device meets them.

The document is a 510(k) summary for the VALIDATE® VIT D Calibration Verification / Linearity Test Kit. It describes the device, its intended use, and states that it is "as safe and effective as the predicate device." However, it does not include the following crucial information that you asked for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document serves as a regulatory submission indicating substantial equivalence to a predicate device, rather than a detailed scientific study report outlining performance metrics against specific acceptance criteria.

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