(72 days)
An enzyme-linked immunosorbant assay (ELISA) for the semiquantitative detection of chromatin reactive antibodies In human serum. The presence of anti-chromatin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).
Not Found
The provided document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ Chromatin ELISA device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, performance data, or details about the study design (sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a study report or a more detailed FDA submission.
Therefore, I cannot directly answer your request using the provided text. The document focuses on the regulatory clearance based on substantial equivalence, not on a detailed presentation of performance data against acceptance criteria.
To answer your request, I would need a different type of document, such as:
- The 510(k) summary or full submission itself
- A clinical study report
- The device's Instructions For Use (IFU) or package insert, which often includes performance data.
§ 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).