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510(k) Data Aggregation
(81 days)
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.
The method-specific reagents are identical with K102673, but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: EliA RF IqM Wells are coated with aggregated rabbit IgG 4 carriers (12 wells each), ready to use; EliA Sample Diluent: 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 IgM Method Reagents: EliA IgM Conjugate 50 or 200: ß-Galactosidase labeled anti-IgM (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 IgM Calibrator Strips: Human IgM (0, 10, 35, 80, 500, 1000 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 IgM Curve Control Strips: Human IgM (80 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 IgM 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 an EliA RF IgM test.
Here's a breakdown of the acceptance criteria and study information for the EliA RF IgM Immunoassay on the Phadia 2500/5000 instruments, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The core of this submission is to demonstrate that the EliA RF IgM Immunoassay, previously cleared on the Phadia 250 instrument (K102673), performs substantially equivalently when used on the new Phadia 2500/5000 instrument platform. Therefore, the acceptance criteria are primarily focused on method comparison and analytical performance to show this equivalence. No explicit "acceptance criteria" are provided as a single table within this document for each performance characteristic, but they are implied by the statistical analyses and cut-offs used.
Here's an organized table presenting the relevant acceptance criteria (implied or stated) and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Precision | Not explicitly stated for each concentration, but typically CV% should be within acceptable clinical limits for diagnostic assays. | EliA RF IgM on Phadia 2500/5000: |
| Mean (IU/mL) | Within-Run SD (%CV) | Between-Run SD (%CV) |
| 1.6 | 0.2 (12.7) | 0.1 (7.1) |
| 3.9 | 0.2 (5.0) | 0.2 (4.5) |
| 7.0 | 0.3 (4.8) | 0.2 (3.1) |
| 73.7 | 1.8 (2.5) | 3.1 (4.2) |
| 169.6 | 7.3 (4.3) | 7.9 (4.6) |
| (Table from Section 10a) | ||
| Linearity | Slope for regression lines should be close to 1, intercept close to 0, R² close to 1. | EliA RF IgM on Phadia 2500/5000: |
| Dilution range (IU/mL) | Slope | Intercept |
| 0.9 - 41.0 | 1.02 | 0.37 |
| 0.9 - 29.2 | 1.02 | 0.18 |
| 2.2 - 195.5 | 0.96 | -1.11 |
| 0.8 - 71.5 | 1.01 | 0.24 |
| (Table from Section 10b) | ||
| Reportable Range | Defined by LoD and upper limit (200 IU/mL). | EliA RF IgM on Phadia 2500/5000: |
| Reportable range: 0.6 to 200 IU/mL. | ||
| Measuring range (LoQ to upper limit): 1.0 to 200 IU/mL. (Section 10b) | ||
| Detection Limit (LoD) | Determined consistent with CLSI EP17-A; proportions of false positives (α) |
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(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 ( |
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