(174 days)
The Diamedix Is-CMV IgG an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convales of child-bearing age. The evaluation of aculture infection, reactivated infection, or resident of primary infection, reactiveled infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with CMV. These reage Automated EIA Processor Automated EIA Processor.
The Is-CMV IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to CMV antigen in human serum
Acceptance Criteria and Device Performance for the Diamedix Is-CMV IgG Test System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve a sensitivity of at least X%"). Instead, it presents performance characteristics from comparison studies and other tests. The "reported device performance" below highlights key metrics from these studies.
| Performance Metric | Acceptance Criteria (Not explicitly stated, but implied by regulatory submission) | Reported Device Performance (Range across studies/sites) |
|---|---|---|
| Relative Sensitivity | High agreement with predicate device | 96.6% - 100.0% |
| Relative Specificity | High agreement with predicate device | 87.8% - 100.0% |
| Overall Agreement | High agreement with predicate device | 97.0% - 99.0% |
| Correlation: Manual vs. MAGO Plus | Strong positive correlation (e.g., R-value close to 1) | R-value: 0.9568 |
| CDC Serum Panel Agreement | High agreement with CDC results (masked characterized panel) | 99% total agreement; 100% agreement for positive and negative samples (both manual and automated) |
| Linearity | Demonstrated linearity throughout reportable range | Representative graphs show linearity over reportable range (R-values > 0.99) |
| Cross-Reactivity | No significant cross-reactivity with common interfering viruses | No cross-reactivity detected with various IgG antibodies (VZV, HSV 1/2, Toxoplasma, Rubella, EBV, Measles) |
| Precision (Interassay CV%) | Acceptable variability (generally |
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).