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The Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. C-Reactive Protein Controls are liquid controls containing human recombinant CRP in a stabilised protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The control materials are available at two constituent concentrations.

This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria, study details, or device performance as typically understood in the context of clinical or diagnostic accuracy studies.

The letter simply states that the Randox Laboratories Ltd. Liquid C-Reactive Protein Controls (Levels II and III) have been found substantially equivalent to a legally marketed predicate device, allowing them to be marketed.

Therefore, for the information requested in your prompt, this document provides:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is a clearance letter, not a performance study report. It does not contain acceptance criteria for device performance or reported performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
4. Adjudication method: Not applicable. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control material, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth is described.
8. The sample size for the training set: Not applicable. No training set is described.
9. How the ground truth for the training set was established: Not applicable. No training set ground truth is described.

In summary, this document is an administrative clearance letter and does not contain the technical study details requested in your prompt.

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