(36 days)
The Olympus Beta-2-Microglobulin reagent is intended for use on Olympus Clinical Chemistry Analzyers for the quantitative determination of Beta-2-Microglobulin in human serum. Measurements of the amount of Beta-2-Microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Not Found
The provided text is a 510(k) clearance letter for the Olympus Beta-2-Microglobulin reagent. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that would typically be found in a detailed device study report.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based only on the provided text. The document is essentially an FDA approval letter, confirming that the device is substantially equivalent to a legally marketed predicate device, but it doesn't detail the performance studies themselves.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.