(19 days)
The Zeus Scientific, Inc. AtheNA Multi-Lyte™ ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of this in namautoimmune disorders. This test is for in vitro diagnostic use.
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The provided text is a 510(k) premarket notification approval letter for the Zeus Scientific, Inc. AtheNA Multi-Lyte™ ANA Test System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed acceptance criteria for device performance, nor does it describe a study that directly proves the device meets those criteria. The letter is an approval based on the submission, not the submission itself.
Therefore, I cannot provide the requested information from this document. To fulfill your request, I would need access to the actual 510(k) submission (K021103) which typically includes summaries of performance studies and their acceptance criteria.
§ 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).