(39 days)
The Diamedix Is anti-β,Glycoprotein I Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is anti B, Glycoprotein I Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum
The provided text describes the performance characteristics of the "Is anti-β₂Glycoprotein I Screen Test System". This device is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM, and IgA antibodies to β₂ glycoprotein I in human serum, intended as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for relative sensitivity, specificity, or overall agreement as a specific numerical threshold that the device must meet to be considered acceptable. Instead, it reports the observed performance and implicitly expects it to be within a reasonable range for an equivalent device. However, for clinical sensitivity and specificity, specific percentages are reported for different patient groups.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Relative Study) | Reported Device Performance (Clinical Study) |
|---|---|---|---|
| Relative Sensitivity | High agreement with predicate | 71.6% (95% CI: 61.0-80.7%) | N/A |
| Relative Specificity | High agreement with predicate | 100.0% (95% CI: 96.2-100.0%) | N/A |
| Overall Agreement | High agreement with predicate | 86.3% (95% CI: 81.4-91.3%) | N/A |
| Clinical Specificity (Normals) | High specificity (implicitly >90%) | N/A | 96.8% (240/248) |
| Clinical Specificity (RPR Positive) | High specificity (implicitly >80%) | N/A | 86.7% (13/15) |
| Clinical Specificity (Other Autoimmune) | High specificity (implicitly >80%) | N/A | 88.2% (30/34) |
| Clinical Sensitivity (APS) | Detects target condition (implicitly >80%) | N/A | 84.2% (48/57) |
| Clinical Sensitivity (SLE) | Detects target condition (implicitly >30%) | N/A | 30.3% (10/33) |
| Manual vs. MAGO Plus Correlation (r) | High correlation (implicitly >0.9) | 0.9667 | N/A |
| Linearity (r) | High linearity (implicitly >0.9) | 0.9904 (95% CI: 0.9456 to 0.9983) | N/A |
| Precision (CV%) - Manual (Interassay) | Low variability (implicitly |
§ 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).