(77 days)
lndications for Use :The Diamedix Is-dsDNA an Enzyme Immunoassay (ElA) for the detection and quantitative determination of IgG antibodies in human serum to DNA antigen as an aid in the diagnosis of systemic lupus erythematosus in patients with clinical signs of the disease. These reagents can be used either manually or in conjunction with the MAGO® Automated EIA Processor.
The Is-dsDNA Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgG to DNA in human serum
Here's an analysis of the provided text regarding the acceptance criteria and study for the Diamedix Is-dsDNA Test System:
Acceptance Criteria and Device Performance
The document does not explicitly state pre-defined quantitative "acceptance criteria" for the study beyond implicitly demonstrating performance relative to a comparative method and typical characteristics for diagnostic assays (linearity, precision, cross-reactivity). The summary focuses on presenting the observed performance rather than comparing it against specific pre-set numerical targets for approval.
However, based on the provided performance characteristics, we can infer some desired outcomes that would constitute "meeting acceptance criteria" in a general sense for a diagnostic device: good sensitivity and specificity, linearity, precision, and lack of significant cross-reactivity.
Here's a table summarizing the reported device performance:
| Performance Metric | Acceptance Criteria (Inferred from industry norms for diagnostic kits) | Diamedix Is-dsDNA Test System Performance (Manual) | Diamedix Is-dsDNA Test System Performance (MAGO) |
|---|---|---|---|
| Relative Sensitivity (vs. comparative method) | Typically high (e.g., >80-90%) | 94.9% (37/39) [95% CI: 82.7-99.4] | 90.6% (29/32) [95% CI: 75.0-98.0] |
| Relative Specificity (vs. comparative method) | Typically high (e.g., >95%) | 100.0% (199/199) [95% CI: 98.2-100] | 100.0% (201/201) [95% CI: 98.2-100.0] |
| Overall Agreement | Typically high (e.g., >90%) | 99.2% (236/238) [95% CI: 97.0-99.9] | 98.7% (230/233) [95% CI: 96.3-99.7] |
| Linearity (R-squared) | High (e.g., >0.95) | 0.9821 (Manual) | 0.9961 (MAGO) |
| Intra-assay Precision (%CV) | Low (e.g., |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).