(136 days)
Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel.
Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.
The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.
The provided document serves as an FDA 510(k) clearance letter for the HEp-2000® Fluorescent ANA/Ro Test System; Image Navigator by Immuno Concepts. While it outlines the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, specific performance metrics, or ground truth establishment.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is an administrative clearance, not a scientific study report.
To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) from the FDA or the original submission's performance data, would be needed.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).