(23 days)
The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. The test is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma.
This document is a 510(k) clearance letter from the FDA for a diagnostic device, the Diastat™ Anti-Cyclic Citrullinated Peptide (anti-CCP) ELISA. It confirms the device's substantial equivalence to a predicate device but does not contain the detailed acceptance criteria or the study data proving the device meets those criteria.
Therefore, I cannot provide the requested information based only on the input provided. The document itself is a clearance letter, not a study report or a summary of performance data.
To answer your request, I would need access to the actual 510(k) submission (K023285) or a detailed performance study report for the Diastat™ Anti-CCP ELISA.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).