(15 days)
The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.
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The provided text describes a 510(k) premarket notification for the "RhiGene MESACUP ANA TEST" and confirms its substantial equivalence to a legally marketed predicate device. However, the document does not contain the specific information required to complete the table and answer the questions about acceptance criteria, study details, ground truth establishment, or sample sizes.
The document is primarily an FDA clearance letter for a medical device (an in-vitro diagnostic test), and as such, it focuses on the regulatory determination of substantial equivalence rather than providing detailed study protocols or results.
To fulfill the request, one would typically need access to the full 510(k) submission, which would include the performance data and the study's design.
Therefore, I cannot provide the requested information based solely on the text provided.
§ 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).