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510(k) Data Aggregation
(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 <64.5 mg/dL Hemoglobin <1 g/dL Lipemia <1250 mg/dL Biotin <100 ng/mL | No interference at: Bilirubin: <37 mg/dL Hemoglobin: <1.1 g/dL Lipemia: <2200 mg/dL Biotin: <100 ng/mL |
Interpretation of Acceptance Criteria:
The acceptance criteria are generally established by comparison to a legally marketed predicate device. The Elecsys® IgE Test aims to demonstrate "substantial equivalence" to the Enzymun-Test® IgE. This means its performance characteristics should be comparable to or better than the predicate, and any differences should not raise new questions of safety or effectiveness.
- Precision: The Elecsys® IgE Test shows comparable or slightly higher %CVs at some points compared to the predicate's reported precision, but also significantly lower %CVs at higher concentrations. The overall precision performance across a wider range of concentrations is provided.
- Lower Detection Limit & Measuring Range: The Elecsys® device demonstrates a significantly improved lower detection limit and a substantially wider measuring range compared to the predicate, which would generally be seen as a positive improvement.
- Specificity: Both devices report no cross-reactivity with other common immunoglobulins, meeting this criterion.
- Method Comparison: The high correlation coefficients (r = 1.0) for both Passing/Bablok and Linear Regression indicate excellent agreement between the Elecsys® IgE Test and the predicate Enzymun-Test® IgE, demonstrating that the new device measures IgE levels similarly to the established method. The 'N = 188' indicates the sample size used for this comparison.
- Interfering Substances: The Elecsys® IgE Test demonstrates non-interference at comparable or higher concentrations for some interfering substances (Hemoglobin, Lipemia) and a slightly lower threshold for Bilirubin, while matching the Biotin threshold of the predicate. This demonstrates robust performance in the presence of common interferents.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the method comparison study, N = 188 samples were used.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It is implied to be data collected to characterize the performance of the new device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is an in vitro diagnostic (IVD) device for quantitative determination of IgE levels. The "ground truth" for the test set (the 188 samples) would be the IgE values obtained using the predicate device (Enzymun-Test® IgE) or a reference method. Therefore, human experts are not directly involved in establishing the ground truth in the same way they would be for image interpretation or clinical diagnosis. The "ground truth" is measured quantitatively by a validated assay.
4. Adjudication Method for the Test Set:
- Not applicable as this is a quantitative IVD device. The "truth" is the measured IgE concentration, not a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes. This is a standalone automated immunoassay. The Elecsys® IgE Test operates without human intervention in the measurement process, once the sample is loaded and the test initiated. Its performance characteristics (precision, detection limit, range, specificity, method comparison) are all reported as "standalone" performance.
7. The Type of Ground Truth Used:
- The ground truth for evaluating the Elecsys® IgE Test's performance (specifically for the method comparison) was generated by comparison to a legally marketed predicate device (Enzymun-Test® IgE). This is a common practice for demonstrating substantial equivalence for IVD devices. The predicate device itself would have been calibrated against a WHO Standard (as stated in the document), which serves as the ultimate reference for IgE quantification.
8. The Sample Size for the Training Set:
- This document is a 510(k) summary for a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" for an algorithm is not applicable. The device's performance is driven by its reagent formulation, instrument design, and chemical reaction principles, not by a trained algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no "training set" in the context of this traditional immunoassay.
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