(231 days)
This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format. The document is an FDA 510(k) clearance letter for the "MININEPH® Human Beta-2 Microglobulin Kit," which primarily outlines the regulatory approval based on substantial equivalence to a predicate device.
It does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Information on experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only states the device's indications for use: "to aid in the diagnosis of active rheumatoid arthritis and kidney disease" by measuring human B2-Microglobulin in serum and urine.
§ 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.