(232 days)
EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells (EliA Celikey IgG Wells, EliA GliadinDP IgA Wells, EliA GliadinDP IgG Wells), EliA Sample Diluent, EliA IgG reagents (EliA IgG Conjugate, EliA IgG Calibrator Strips, EliA IgG Curve Control Strips, EliA IgG Calibrator Well), and EliA IgA reagents (EliA IgA Conjugate, EliA IgA Calibrator Strips, EliA IgA Curve Control Strips, EliA IgA Calibrator Well). 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 Celikey IgG and EliA GliadinDP IgA and EliA GliadinDP IgG tests.
The provided document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence determination for the Phadia AB EliA Immunoassays (Celikey IgG, GliadinDP IgA, GliadinDP IgG) for use on the Phadia 2500/5000 instrument. The document primarily focuses on demonstrating that the performance of these assays on the new instrument platform is substantially equivalent to their performance on a previously cleared instrument (Phadia 250).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a single table outlining "acceptance criteria" alongside "reported device performance" for the overall substantial equivalence determination. Instead, it details performance characteristics for various analytical aspects, and the acceptance criteria are implied by the ranges and thresholds specified for these studies. The primary "acceptance criteria" for the overall submission appear to be demonstrating equivalence to the predicate device and meeting specific statistical thresholds for precision and linearity.
However, based on the sections "M. Performance Characteristics (if/when applicable)" and "2. Comparison studies: - Instrument comparison C.", we can construct a table for the analytical performance and comparative study results:
Table: Acceptance Criteria (Implied) and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied from stated goals or predicate performance) | Reported Device Performance (Phadia 2500/5000) |
|---|---|---|
| Precision | Variability assessed across 21 runs (3 instruments x 7 runs) for each assay. (No explicit %CV targets given, but comparison to typical acceptable analytical variation in such assays is implied). CLSI EP05-A3 guidelines followed. | EliA Celikey IgG: Total Imprecision (%CV): 27.9% (at 1.6 EliA U/mL), 5.9% (at 7.6), 6.6% (at 9.6), 5.1% (at 104.4), 5.3% (at 274.6). |
| EliA GliadinDP IgA: Total Imprecision (%CV): 18.2% (at 0.8), 3.6% (at 7.4), 4.5% (at 8.7), 5.0% (at 42.8), 9.3% (at 135.3). | ||
| EliA GliadinDP IgG: Total Imprecision (%CV): 13.0% (at 3.6), 7.0% (at 7.2), 5.9% (at 9.3), 8.1% (at 73.7), 7.7% (at 219.6). | ||
| Linearity/Reportable Range | Assays should demonstrate linearity across their measurement range. CLSI EP06-A guidelines followed. "Slope for the regression lines should be 0.9 - 1.1... and intercept close to 0." | EliA Celikey IgG: Slope: 1.01-1.04, Intercept: 0.49-2.48, R2: 0.99-1.00. |
| EliA GliadinDP IgA: Slope: 0.99-1.00, Intercept: -1.69-0.79, R2: 1.00. | ||
| EliA GliadinDP IgG: Slope: 0.98-1.00, Intercept: -5.65-1.02, R2: 0.99-1.00. | ||
| All R2 values are very close to 1, indicating strong linearity. | ||
| Limit of Detection (LoD), Limit of Quantitation (LoQ) | Determined consistent with CLSI EP17-A2 guidelines; proportions of false positives (α) |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).