(47 days)
The RhiGene ANA ELISA TEST SYSTEM is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene ANA ELISA TEST SYSTEM is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.
The RhiGene ANA ELISA TEST SYSTEM uses a mixture of recombinant purified proteins of Jo-1, RNP, SS-A, SS-B, Scl-70, CENP-B and native purified proteins of SS-A, Sm, dsDNA and ssDNA for the solid phase antigen. Therefore, the test shows increased specificity for detection of disease-specific connective tissue diseases such as SLE, Progressive Systemic Sclerosis, Mixed Connective Tissue Diseases, Sjögren's Syndrome, and Polymyositis.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "RhiGene ANA ELISA TEST SYSTEM." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain the requested information about acceptance criteria or a study proving the device meets them.
The document states the device's indications for use and mentions it's a semi-quantitative ELISA for detecting disease-specific antinuclear antibodies in human serum, intended as an aid in determining certain autoimmune diseases. It also lists the specific antigens used.
However, it does not include any performance data, study designs, sample sizes, ground truth establishment, or expert information. Therefore, I cannot provide a table of acceptance criteria or details of a study from this document.
§ 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).