(54 days)
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 2500/5000.
The method-specific reagents are identical with K132631 (EliA SmDº on Phadia 250), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:
- Test Wells: -EliA SmDP Wells are coated with a synthetic SmD3 peptide – 4 carriers (12 wells each), ready to use;
- EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
- -EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide – 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
- EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
- -EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.
The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA SmDP tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review is the EliA SmDP Immunoassay on the Phadia 2500/5000 instrument. The study primarily evaluated the performance of this new instrument platform compared to a previously cleared device (EliA SmDP on Phadia 250, K132631). The acceptance criteria for the new device's performance are largely demonstrated through its equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (typically from predicate or internal) | Reported Device Performance (EliA SmDP on Phadia 2500/5000) |
|---|---|---|
| Precision/Reproducibility | Not explicitly stated as a specific numerical range for the new device, but implied to be acceptable if similar to the predicate and overall low variability. The previous submission (K132631) likely established this. | Total Imprecision (%CV): |
- 24.8% at 2.2 EliA U/mL
- 8.8% at 10.0 EliA U/mL
- 6.5% at 146.6 EliA U/mL
- 8.8% at 408.1 EliA U/mL
(within acceptable limits for immunoassays of this type) |
| Linearity/Reportable Range | Implied to be linear across the measuring range, with slopes close to 1 and R2 values close to 1. | Linearity (Slope, 95% CI): - 1.04 (0.95-1.12)
- 0.98 (0.94-1.02)
- 1.01 (0.97-1.05)
- 1.01 (0.99-1.02)
R2 values: All 0.99 or 1.00
Linear Range: 1.6 EliA U/mL (LoQ) to 480 EliA U/mL (upper limit)
Reportable Range: 0.8 EliA U/mL (LoD) to 480 EliA U/mL (upper limit) |
| Detection Limit (LoD) | Not explicitly stated as a specific numerical value. The study aimed to determine it. | LoD: 0.8 EliA U/mL (with
§ 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).