(309 days)
The IMMULITE 2000 Anti-CCP IgG assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA or lithium heparin) on the IMMULITE 2000 system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.
The IMMULITE 2000 Anti-CCP IgG Calibration Verification Material (CVM) is for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Anti-CCP IgG assay on the IMMULITE 2000 system.
The IMMULITE 2000 Anti-CCP IgG assay consists of the following components:
- Anti-CCP IgG bead pack coated with cyclic citrullinated peptide . (CCP) antigen
- Anti-CCP IgG reagent wedge containing bovine calf intestine . conjugated to a monoclonal murine anti-human IgG antibody
- Anti-CCP IgG adjustors, low and high, containing lyophilized . human serum with IgG reactive to CCP
- Anti-CCP IgG controls, negative and positive, containing human . serum
- . Autoantibody sample diluent containing protein/buffer matrix
The IMMULITE Anti-CCP IgG Calibration Verification Material consists of one set of four vials, containing low, intermediate and high levels of lyophilized human serum with IgG reactive to cyclic citrullinated peptide (CCP), in buffer with preservative, plus an anti-CCP-free sample.
The IMMULITE® 2000 Anti-CCP IgG Assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP). It is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a single, consolidated table. However, performance characteristics are reported, which implicitly define what the manufacturer considers acceptable for their device to perform as intended and to demonstrate substantial equivalence to the predicate device. Based on the performance characteristics presented, the following can be inferred as the "acceptance criteria" through the demonstrated results.
| Performance Characteristic | Acceptance Criteria (Implicit from Results) | Reported Device Performance |
|---|---|---|
| Precision (Total CV%) | Generally, Coefficients of Variation (CV%) for diagnostic assays should be within acceptable limits (e.g., |
§ 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).