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The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in a wide range of laboratory applications, particularly Immunoassay analysis. The product is available at three constituent concentrations. Each level is available in a 5ml final re-constituted volume. The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on lyophilised human serum.

The provided text is a 510(k) clearance letter from the FDA for "Assayed Immunoassay Controls" from Randox Laboratories Ltd. This document does not describe acceptance criteria or a study proving device performance as typically expected for an AI/ML or imaging device. Instead, it is a regulatory document confirming substantial equivalence of a quality control material to a predicate device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The device in question is a laboratory quality control material, not a device that would typically undergo the kind of performance studies involving AI, human readers, or ground truth establishment that your questions imply.

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