(269 days)
The EUROIMMUN IFA Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitative determination of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN IFA Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.
The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitation of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) and the qualitative determination of IgG anti-MPO, and, if included, anti-GBM antibodies in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.
Not Found
The provided text is a 510(k) premarket notification decision letter from the FDA. It does not contain information about the acceptance criteria and study details for the device's performance. The letter primarily focuses on the regulatory determination of substantial equivalence and general device regulations.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).