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510(k) Data Aggregation
(258 days)
IS-RUBELLA IGG TEST SYSTEM
The Diamedix Is-Rubella IgG Test Kit is an Enzyme Immunoassay (EIA) for the qualitative and quantitative determination of IgG antibodies in human serum to aid in the assessment of the patient's immunological response to infection with rubellaand in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of recent or current infection with rubella. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is-Rubella IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative and quantitative detection of IgG to rubella in human serum. Partially purified rubella antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the rubella antigen are present in the patient sample they will bind to the antigen on the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from the prior step, the reaction is stopped and the color intensity is measured photometrically producing an indirect measure of the specific antibody present in the patient sample.
Here's a breakdown of the acceptance criteria and the study details for the Diamedix Is-Rubella IgG Test System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific quantitative thresholds that the device must meet to be considered effective. Instead, it presents performance characteristics in comparison to existing marketed tests (predicate devices) and a CDC reference panel. The overall goal appears to be demonstrating substantial equivalence to these predicate devices.
However, we can infer performance targets from the reported results, particularly overall agreement, sensitivity, and specificity. The data is presented as a comparison, implying that similar performance to established methods is the 'acceptance criteria.'
| Metric | Acceptance Criteria (Implied from predicate performance/benchmark) | Reported Device Performance (Range Across Sites/Methods) | Study Section Where Found |
|---|---|---|---|
| Relative Sensitivity (Qualitative) | High agreement with predicate (e.g., >95%) | 93.3-100.0% (Site #1: 97.1%; Site #2: 100.0%; Site #3 Manual: 98.1%; Site #3 MAGO Plus: 99.5%) | A. Comparison Testing |
| Relative Specificity (Qualitative) | High agreement with predicate (e.g., >95%) | 82.4-100.0% (Site #1: 100.0%; Site #2: 83.8%; Site #3 Manual: 100.0%; Site #3 MAGO Plus: 100.0%) | A. Comparison Testing |
| Overall Agreement (Qualitative) | High agreement with predicate (e.g., >95%) | 92.2-99.6% (Site #1: 97.4%; Site #2: 96.3%; Site #3 Manual: 98.4%; Site #3 MAGO Plus: 99.6%) | A. Comparison Testing |
| Agreement with CDC Panel (Negative) | 100% | 100% (Manual & Automated) | C. CDC Serum Panel Data |
| Agreement with CDC Panel (Positive) | High (e.g., >95%) | 97.6% (Manual & Automated) | C. CDC Serum Panel Data |
| Correlation (Manual vs. Automated) | Strong positive linear correlation (r approaching 1) | r = 0.9550 | B. Correlation of Manual and MAGO Plus Results |
| Linearity (R-squared) | High (e.g., >0.99) | R-squared: 0.9933 (Manual), 0.9969 (MAGO Plus) | C. Linearity |
| Correlation to WHO Standard (R-squared) | High (e.9, >0.98) | R-squared: 0.9846 | D. Correlation to WHO Standard |
| Lack of Cross-Reactivity | No cross-reactivity with common viral antibodies | 0 positive results for rubella IgG in samples positive for other viruses | F. Cross-Reactivity Data |
| Precision (CV%) | Lower CV% preferred, especially for quantitative assays. Typically |
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