(27 days)
The & PR-3 IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Proteinase-3 antigen in serum as an aid in the diagnosis of Wegeners granulomatosis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.
The & PR-3 IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Proteinase-3 in human serum.
Here's a breakdown of the acceptance criteria and the study details for the Columbia Bioscience, Inc. & PR-3 IgG ELISA Kit based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the results presented in the performance studies, showing that the device achieved these values. Explicit pre-defined acceptance thresholds are not directly stated in the summary, but the reported performance serves as the basis for substantial equivalence.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | High (e.g., >90%) | 100.0% (95% CI: 93.7-100%) |
| Relative Specificity | High (e.g., >95%) | 97.9% (95% CI: 94.7-99.4) |
| Overall Agreement | High (e.g., >95%) | 98.4% (95% CI: 95.9-99.6) |
| Clinical Specificity (Normals) | High (e.g., >95%) | 98.3% (95% CI: 95.0-99.6) |
| Clinical Sensitivity (Wegener's Granulomatosis) | High (e.g., >90%) | 95.0% (95% CI: 83.1-91.4) |
| Clinical Sensitivity (Microscopic Polyangiitis) | Acceptable (Specific target not clear, but 55.3% is reported) | 55.3% (95% CI: 38.3-71.4) |
| Correlation (Manual vs. MAGO Plus) | Strong positive correlation | Pearson Correlation Coefficient: 0.983 |
| Precision (Intra-assay CV%) | Low variability (e.g., 90% or >95%), and for precision, Coefficient of Variation (CV%) values are expected to be low (e.g., |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).