(77 days)
The assay is intended for use in detecting antibodies to SSB (La) antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
The Is-anti-SSB Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to SSB (La) antigen in human serum.
Here's a breakdown of the acceptance criteria and study information for the Diamedix Is-anti-SSB Test System, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied) | Reported Device Performance (Manual) | Reported Device Performance (MAGO) |
|---|---|---|---|
| Relative Sensitivity | High sensitivity for detecting autoantibodies (e.g., ≥ 80-90%) | 95% (38/40 sera) | 95% (38/40 sera) |
| Relative Specificity | High specificity to avoid false positives (e.g., ≥ 95%) | 100% (124/124 sera) | 100% (124/124 sera) |
| Agreement | High concordance with a predicate device (e.g., ≥ 95%) | 99% (162/164 sera) | 99% (162/164 sera) |
| Linearity | Strong linear relationship between dilution and absorbance | R² = 0.9829 (Manual) | R² = 0.9874 (MAGO) |
| Precision | Low intra- and inter-assay variability (e.g., CV% |
§ 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).