(35 days)
An enzyme-linked immunosorbant assay for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere, and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested in the prompt. The document is an FDA 510(k) clearance letter for the QUANTA Lite™ ANA ELISA device, which confirms substantial equivalence to a predicate device. While it mentions the intended use of the device, it does not include specifics about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This letter primarily serves as a regulatory approval notice, not a detailed technical report of device 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).