(104 days)
The Diamedix Immunosimplicity ANA (Is-ANA) Screen is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double stranded DNA (dsDNA, nDNA), Histones, SSA/Ro, SSB/La, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO™ Automated EIA Processor [510(k) number K973177]. For In Vitro Diagnostic Use.
The Diamedix Immunosimplicity ANA (Is-ANA) Screen is a qualitative enzyme immunoassay (EIA).
I am sorry, but the provided text only contains regulatory correspondence from the FDA regarding a 510(k) premarket notification for the "Diamedix Immunosimplicity ANA (Is-ANA) Screen Test." It grants permission to market the device and describes its intended use.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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).