(67 days)
For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.
The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.
Here's a breakdown of the acceptance criteria and study information for the Elecsys® IgE Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (Elecsys® IgE Test) |
|---|---|---|
| Precision | Within-Run %CV | |
| Within-Run %CV: | ||
| ~2.1% at 102.7 IU/mL | ||
| ~2.1% at 244.1 IU/mL | ||
| ~2.8% at 375.4 IU/mL | 3.6% at 5.18 IU/mL | |
| 2.1% at 105 IU/mL | ||
| 2.8% at 197 IU/mL | ||
| 3.2% at 398 IU/mL | ||
| 2.4% at 1010 IU/mL | ||
| Total %CV | Total %CV | |
| Total %CV: | ||
| ~3.4% at 102.7 IU/mL | ||
| ~3.4% at 244.1 IU/mL | ||
| ~3.6% at 375.4 IU/mL | 4.2% at 5.18 IU/mL | |
| 1.9% at 105 IU/mL | ||
| 3.9% at 197 IU/mL | ||
| 3.9% at 398 IU/mL | ||
| 3.1% at 1010 IU/mL | ||
| Lower Detection Limit | 1.44 IU/mL (Predicate) | 0.10 IU/mL |
| Measuring Range | 1.44 - 500 IU/ml (Predicate) | 0.10 - 4000 IU/ml |
| Specificity | No cross-reactions with IgG, IgA, and IgM (Predicate) | No cross-reactivity with the immunoglobulins G, A, and M was detected. |
| Method Comparison | Evidence of strong correlation (e.g., r close to 1) with the predicate device. | Elecsys IgE vs Enzymun-Test IgE |
| Passing/Bablok: y = -0.53 + 0.97x, r = 1.0, SD (md68) = 2.42, N = 188 | ||
| Linear regression: y = -1.85 + 1.01x, r = 1.0, Sy.x = 5.86, N = 188 | ||
| Interfering Substances | No interference at predicate's concentrations: | |
| Bilirubin |
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).