(55 days)
For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody. These reagents can be used either manually or in conjunction with the MAGO® or MAGO® PLUS Automated EIA Processors.
The Is-ENA-6 Screen Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to six extractable nuclear antigens (ENAs), in human serum.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or agreement that the device must meet to be considered acceptable. Instead, it presents the performance characteristics of the Is-ENA-6 Screen Test System and compares them to a "comparative method" (a predicate device). The implication is that performance comparable to or better than the predicate device, across multiple testing modalities (manual, MAGO, MAGO PLUS), constitutes acceptable performance.
However, based on the reported performance, we can infer what might be considered acceptable by showing strong correlation and similar diagnostic accuracy to the predicate device.
Inferred Acceptance Criteria & Reported Device Performance Table:
| Performance Metric | Inferred Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Worst Case across Manual, MAGO, MAGO PLUS) |
|---|---|---|
| Relative Sensitivity | High (e.g., >80% and comparable to predicate) | 92.0% (84.3-96.7% CI) |
| Relative Specificity | High (e.g., >90% and comparable to predicate) | 97.2% (93.1-99.2% CI) |
| Overall Agreement | High (e.g., >90% and comparable to predicate) | 95.3% (91.8-97.6% CI) |
| Precision (Intra-assay 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).