(267 days)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgG antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative detection of Rheumatoid Factor IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of theumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
Not Found
This document is a 510(k) Premarket Notification from the FDA regarding the ImmuLisa Enhanced™ RF IgA Antibody ELISA, ImmuLisa Enhanced™ RF IgG Antibody ELISA, ImmuLisa Enhanced™ RF IgM Antibody ELISA, and ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISA. It doesn't contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information such as:
- Trade/Device Name: ImmuLisa Enhanced™ RF IgA Antibody ELISA, ImmuLisa Enhanced™ RF IgG Antibody ELISA, ImmuLisa Enhanced™ RF IgM Antibody ELISA, ImmuLisa Enhanced™ RF IgA/IgG/IgM Antibody ELISA
- Regulation Number: 21 CFR 866.5775
- Regulation Name: Rheumatoid factor immunological test system
- Regulatory Class: Class II
- Product Code: DHR
- Indications for Use: Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Rheumatoid Factor IgA, IgG, and/or IgM antibodies in human serum to aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other laboratory tests and clinical findings.
- Type of Use: Prescription Use
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).