(63 days)
An enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of antibodies to thyroid peroxidase (TPO) in human serum to aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves Disease.
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The provided document is a 510(k) clearance letter from the FDA for a device called "Quanta Lite TPO ELISA." This document primarily focuses on regulatory approval and does not contain the specific technical details, acceptance criteria, or study results you've requested regarding device performance.
Therefore, I cannot provide the information requested in your prompt based on the provided text. The document confirms that the device is substantially equivalent to a predicate device for the stated indications for use, but it does not detail the underlying performance studies or acceptance criteria themselves.
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§ 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).