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The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on Ivophilised human serum and have been developed for the control of accuracy and precision in clinical chemistry, at three constituent concentrations. These control materials are intended for use in therapeutic drug monitoring. The Randox Human Drug Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on Ivophilised human serum and have been developed for the control of accuracy and precision in clinical chemistry, at three constituent concentrations.

The provided document is a 510(k) premarket notification letter from the FDA for "Human Drug Controls Levels I, II and III". This document describes the FDA's decision regarding the substantial equivalence of this device to a predicate device.

It does not contain information about:

• Acceptance criteria for device performance.
• Any study that proves the device meets specific acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states the "Indications For Use" for the device, which are: "The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of accuracy and precision in clinical chemistry, at three constituent concentrations, for therapeutic drug monitoring." However, it does not specify performance metrics or acceptance thresholds.

Therefore, I cannot provide the requested information from the given text.

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