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N/T Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum using BN* Systems and the TurbiTimeSystem.

N/T Rheumatology Controls SL (bi-level control; N/T Rheumatology Control SL/1 and N/T Rheumatology Control SL/2) is a multi-constituent control intended for use as a quality control material to monitor the accuracy and precision of selected rheumatic and inflammatory disease with the BN and Behring TurbiTime Systems.

The provided text describes a 510(k) submission for N/T Rheumatology Controls SL, a quality control material. However, it does not include information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

The document is a summary of the 510(k) submission and the FDA's response approving the device for marketing. It primarily focuses on:

• Manufacturer and contact information.
• Device name, classification, and predicate device.
• Device description and intended use.
• A brief mention of stability testing protocols but no specific performance metrics or acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or adjudication methods based on the provided text. The document is an administrative filing rather than a scientific study report.

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