(245 days)
EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 100.
EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 250.
The Phadia EliA immunodiagnostic system is automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA Scl-70° test.
The acceptance criteria and study detailed in the provided document pertain to the EliA™ Scl-70S Immunoassay, an in vitro semi-quantitative test for IgG antibodies directed to Scl-70.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical performance (sensitivity and specificity). However, it reports the performance of the EliA Scl-70S based on its clinical study. For analytical performance, the acceptance criteria are implied by the reported results meeting generally accepted ranges for such assays.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (EliA Scl-70S) |
|---|---|---|
| Analytical Performance | ||
| Precision/Reproducibility | ||
| Phadia 100 (Total %CV) | Low ( |
§ 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).