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The use of control material to estimate test precision in a test system and to detect systematic deviation that may arise from reagent or analytical instrument variation in the measurement of cyclosporine A, tacrolimus and rapamycin.

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This document is a 510(k) clearance letter from the FDA for a quality control material called "Rap/Tac/CsA Control." It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a control material for estimating test precision and detecting systematic deviation in a test system, not a diagnostic device itself.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls. The "Indications for Use" section further clarifies its purpose as a quality control material.

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