(40 days)
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.