(64 days)
The assay is intended for use in detecting antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE).
The dsDNA Immunoglobulin EIA test system is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of Immunoglobulin to dsDNA in human sera.
This document describes the validation of the MarDx dsDNA Immunoglobulin EIA Test System, a device for detecting antibodies to dsDNA in human sera, intended as an aid in diagnosing Systemic Lupus Erythematosus (SLE).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy for the MarDx dsDNA EIA Test System. Instead, it demonstrates substantial equivalence to a predicate device (Clark ELISA for dsDNA IgG, IgM antibodies) by presenting the comparative performance.
However, based on the results, we can infer the desired performance levels relative to the predicate device. For precision, the acceptance criteria are implicit in the reported Coefficient of Variation (CV) values.
| Performance Metric | Acceptance Criteria (Implied / Achieved) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | Substantial equivalence to Clark dsDNA test (implicitly, high sensitivity) | 95.0% (38/40 true positives relative to the Clark test) |
| Relative Specificity | Substantial equivalence to Clark dsDNA test (implicitly, high specificity) | 100% (81/81 true negatives relative to the Clark test) |
| Relative Accuracy | Substantial equivalence to Clark dsDNA test (implicitly, high accuracy) | 98.3% (119/121 agreement relative to the Clark test) |
| Intra-Assay Precision (CV) | Generally, |
§ 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).