(49 days)
The QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies 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 Sjögren's syndrome, scleroderma and polymyositis.
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This is a 510(k) premarket notification for an in vitro diagnostic device, the QUANTA Plex™ ENA Profile 6. The provided text is a letter from the FDA determining substantial equivalence to a predicate device, along with the "Indications For Use" statement.
The document does not contain the acceptance criteria, study details, or performance data for the QUANTA Plex™ ENA Profile 6 being reviewed. It only confirms the FDA's decision based on the information submitted by the manufacturer.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications from this document. This kind of detailed information is typically found in the full 510(k) submission, specifically in sections describing device performance studies and validation.
§ 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).