(39 days)
The ORGENTEC ANA Detect assay 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, ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-A-La, Sm, SmRNP, Scl-70, Jo-1, and centromeric antigens.
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The provided text is a 510(k) clearance letter from the FDA for the device "ANA Detect". This type of document typically confirms that a device is substantially equivalent to a predicate device and can be marketed. It does not usually contain the detailed study results or acceptance criteria themselves, but rather refers to the submission document where such information would reside.
Therefore, the provided document does not contain the specific acceptance criteria for the ANA Detect device, nor a detailed description of the study that proves the device meets those criteria.
The text only states that the device is an "ANA Detect" and its indications for use are to "screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases." It also lists the specific autoantigens the assay collectively detects.
To answer your request thoroughly, the original 510(k) submission (K030929) would need to be consulted, as that document would contain the detailed performance data, acceptance criteria, study design, and statistical analysis.
Without access to the actual 510(k) submission, I cannot provide the requested table and detailed information.
§ 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).