(86 days)
The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is anti-Cardiolipin IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum
Here's a breakdown of the acceptance criteria and study details for the Diamedix Is-anti-Cardiolipin IgG/IgM Test System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined quantitative acceptance criteria with specific numerical targets. Instead, it describes performance characteristics and then presents the results. The implicit acceptance criteria are that the device demonstrates comparable performance to a commercially available predicate device and satisfactory analytical and clinical performance.
| Performance Metric | Indication of Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Calibration Equivalence | 3-point vs. 6-point calibration should show strong correlation. | IgG: Y = 2.4036 + 0.9996X (r = 0.9861, n=172). IgM: Y = 0.5333 + 0.9411X (r = 0.9925, n=162). (Strong linear correlation demonstrated for both.) |
| Relative Sensitivity (IgG) | Should be comparable to commercially available ELISA kit. | 91.5% (95% CI: 79.6-97.6%) |
| Relative Specificity (IgG) | Should be comparable to commercially available ELISA kit. | 100.0% (95% CI: 96.6-100.0%) |
| Overall Agreement (IgG) | Should be comparable to commercially available ELISA kit. | 97.4% (95% CI: 93.5-99.3%) |
| Relative Sensitivity (IgM) | Should be comparable to commercially available ELISA kit. | 78.4% (95% CI: 67.3-87.1%) |
| Relative Specificity (IgM) | Should be comparable to commercially available ELISA kit. | 100.0% (95% CI: 95.8-100.0%) |
| Overall Agreement (IgM) | Should be comparable to commercially available ELISA kit. | 90.1% (95% CI: 84.4-94.2%) |
| Clinical Specificity (IgG) | High specificity in normal population, acceptable specificity in other autoimmune diseases. | Normals: 99.5% (213/214), RPR Positive: 73.3% (11/15) |
| Clinical Specificity (IgM) | High specificity in normal population, acceptable specificity in other autoimmune diseases. | Normals: 98.5% (211/214), RPR Positive: 73.3% (11/15) |
| Clinical Sensitivity (IgG) | Detectable in patients with APS and SLE. | APS: 82.5% (47/57), SLE: 21.2% (7/33), Other Autoimmune Diseases: 8.6% (3/35) |
| Clinical Sensitivity (IgM) | Detectable in patients with APS and SLE. | APS: 47.4% (27/57), SLE: 21.2% (7/33), Other Autoimmune Diseases: 14.2% (5/35) |
| Cross Reactivity | Should show minimal cross-reactivity with other common autoantibodies. | Out of 36 samples tested (SSA/SSB, Scl-70, Jo-1, dsDNA, RF), one sample positive for dsDNA showed a positive result. The remaining 34 samples were negative. (Suggests minimal cross-reactivity with most, but potential with dsDNA.) |
| Linearity (IgG) | Demonstrates a linear response over a range of concentrations. | Y = -4.9960 + 147.5101 X (r = 0.9957, R² = 0.9915). |
| Linearity (IgM) | Demonstrates a linear response over a range of concentrations. | Y = 4.0837 + 87.9931 X (r = 0.9849, R² = 0.9701). |
| Manual vs. Automated (IgG) | Manual and MAGO Plus methods should show strong correlation. | Y = 1.1058 + 1.1976 X (r = 0.9883, n=172). 6-point (automated vs. manual): (automated) = 1.0696 (manual) + 4.0821; 95% CI slope [1.0174 to 1.1218], intercept [1.3042 to 6.8600]. (Strong linear correlation demonstrated.) |
| Manual vs. Automated (IgM) | Manual and MAGO Plus methods should show strong correlation. | Y = 1.3732 + 1.1510 X (r = 0.9917, n=162). 6-point (automated vs. manual): (automated) = 1.0169 (manual) + 2.2121; r=0.9772; 95% CI slope [0.9824 to 1.0514], intercept [1.1343 to 3.2899]. (Strong linear correlation demonstrated.) |
| Precision (CV%) | Coefficients of Variation (CV%) for intra-assay and interassay should be within acceptable limits (typically |
§ 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).