(62 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of ten and the country liness of . DAR in byen secure Enzyme intiked minialioscroom and "ANP in human serum.
Uses:
The results of the anti-Sm/RNP assay can be used as an aid in the diagnosis of auto-immune I he results of the anti-Sits Reviews assure Disease (MCTD).
diseases including Mixed Connective Tissue Disease (MCTD).
For in vitro diagnostic use only.
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The provided document is a 510(k) clearance letter from the FDA for the Autostat™ II Anti-Sm/RNP ELISA device.
This document does not contain the detailed study information required to answer your request, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or multi-reader multi-case study results.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the FDA's decision is based on a determination of substantial equivalence to a predicate device, rather than a detailed presentation of novel clinical study results with specific performance statistics against predefined acceptance criteria for this new device. The 510(k) submission itself would contain such data, but this letter is merely the FDA's response to that submission.
§ 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).