(45 days)
The QUANTA Plex™ SLE Profile 8 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, SCL-70, Jo-1, Ribosomal P and Centromere B autoantibodies in human serum. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as mixed connective tissue disease, Sjogren's syndrome, scleroderma and polymyositis.
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This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The document is primarily the FDA's formal response to a premarket notification for the "QUANTA Plex™ SLE Profile 8" device, confirming its substantial equivalence to legally marketed predicate devices. It briefly states the indications for use on page 6 (document page 3).
§ 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).