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The IgE assay is intended for use in the quantitative determination of Total Immunoglobulin E (lgE) concentration in human serum and plasma (lithium heparin, K2-EDTA, K3-EDTA, K3-EDTA) on Beckman Coulter AU/DxC AU clinical chemistry analyzers. The determination aids in the diagnosis of IgEmediated allergic disorders in conjunction with other clinical findings. For in vitro diagnostic use only.

The Total Immunoglobulin E (IgE) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's AU/DxC AU clinical chemistry analyzers. Each reagent kit contains one buffer reagent (R1), one antibody reagent (R2), and a six-level lot matched calibrator set. The IgE reagent test system utilizes a turbidimetric immunoassay methodology. The AU analyzer measures the change in absorbance at 800 nm to calculate and express the concentration of immunoglobulin E in the test sample based on a stored calibration curve. The IgE assay is traceable to the World Health Organization (WHO) 3rd International Standard 11/234.

The provided document is a 510(k) Premarket Notification for the Beckman Coulter Total Immunoglobulin E (IgE) assay. It describes the device's performance characteristics and how they meet established acceptance criteria, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several tables detailing acceptance criteria and study results for different performance parameters.

Table 1: Method Comparison Summary (from Table 9.1.1)

This table compares the Beckman Coulter IgE Assay (candidate device) against the Roche Elecsys IgE II Assay (predicate device).

Table 2: Precision Performance Summary (from Table 9.2.1)

Note: For Pool 1, the document states criteria of "≤5.0 IU/mL" for repeatability and "≤7.0 IU/mL" for total precision. The reported results are 2.1 IU/mL (repeatability) and 2.3 IU/mL (total precision), which meet these criteria.

Table 3: Analytical Range (Linearity) Study Summary (from Table 9.3.1)

Further breakdown of linearity criteria for individual points in Table 9.3.2 shows "Bias Spec" of 10.0 for values ≤100 IU/mL and "%Bias Spec" of 10.0 for values > 100 IU/mL. All individual points "Pass".

Table 4: Detection Limit Study Summary (LoB, LoD & LoQ) (from Table 9.4.1)

Table 5: Anticoagulant Study Results Summary (from Table 9.7.1)

Table 6: In-Use Stability Study Summary (from Table 9.8.1)

Note: For the stability studies, the acceptance criteria are implicitly met if the "Pass" status is indicated after testing beyond the claimed duration, implying that the mean IgE recovery criteria (within 10 IU/mL or 10% of Day 0 mean) were met.

2. Sample sizes used for the test set and the data provenance

• Method Comparison: 136 fresh serum samples spanning the analytical measuring range. Provenance not explicitly stated.
• Precision: Three lots of IgE reagent, tested using two levels of human serum-based quality control material and three patient pools. The experimental design used duplicate sample analysis twice daily over twenty working days (N=80 results for each control/pool). Provenance not explicitly stated.
• Linearity: 15-level linearity test set of inter-diluted patient pools. Provenance not explicitly stated.
• Sensitivity (LoB, LoD, LoQ): LoB evaluated four unique lots of Immunoglobulin (Ig)-depleted human serum. LoD and LoQ used native patient pools diluted with Ig-depleted serum. Provenance not explicitly stated.
• Analytical Specificity (Interference): Test samples containing various interferents (Hemoglobin, Bilirubin, Lipemia, RF, 21 common drugs and concentrations). Specific sample sizes per interferent are not given but are implied by tables (e.g., "Level Tested"). Provenance not explicitly stated.
• Anticoagulant Studies: Freshly drawn serum and plasma from apparently healthy adult volunteer donors. Five specimen tubes were drawn from each donor: one serum tube and one tube of each type of anticoagulant. Sample sizes listed for each anticoagulant type: Na Heparin (N=55), Li Heparin (N=55), K2 EDTA (N=55), K3 EDTA (N=53). Provenance not explicitly stated.
• In-Use Stability: Three levels of quality control material were evaluated. Specific N is not detailed, but implied by the "classical design for sampling, storage, and testing." Provenance not explicitly stated.

Generally, the data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned for any of the studies in the provided document. The studies appear to be prospective analytical performance studies designed to evaluate the device's technical specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is an in vitro diagnostic (IVD) quantitative assay for Total IgE. The "ground truth" for such devices is typically established through:

• Traceability to International Standards: The IgE assay is stated to be traceable to the World Health Organization (WHO) 3rd International Standard 11/234. This is a primary method of establishing "ground truth" for quantitative lab tests, where the standard itself defines the "true" concentration.
• Reference Methods: The method comparison study uses a legally marketed predicate device (Roche Elecsys IgE II Assay) as the comparative "truth" or reference standard for patient samples. The predicate device itself would have undergone similar rigorous validation, likely traceable to international standards.

Therefore, for this type of device, the concept of "experts" in the sense of clinicians or radiologists establishing a diagnostic "ground truth" for individual cases (like in an imaging study) is not directly applicable. The "ground truth" for the test set is inherent in the certified international standard and the established performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 consensus are typically used in studies involving subjective interpretation (e.g., imaging reads) to establish a consensus ground truth. For quantitative in vitro diagnostic assays, the "truth" is determined by reference methods, international standards, and analytical evaluation against defined statistical criteria, not by human consensus or adjudication of individual results.

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

Not applicable. This is an in vitro diagnostic (IVD) assay, not an AI-powered diagnostic imaging device or an AI-assisted interpretation tool for human readers. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" do not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are all "standalone" in the sense that they evaluate the performance of the analytical instrument and reagent system itself (the "algorithm only" in a broader sense of the measurement process) without direct human intervention in the result generation or interpretation step for the purpose of the performance evaluation. The device provides a quantitative result (IgE concentration), which is then used by clinicians in conjunction with other clinical findings. The performance data (e.g., precision, linearity, sensitivity, method comparison) directly reflects the device's inherent analytical capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this IgE assay is established primarily through:

• International Standards: The assay's traceability to the WHO 3rd International Standard 11/234 is explicitly stated and serves as the ultimate reference for IgE concentration.
• Reference Measurement Procedures/Predicate Device: For method comparison, the Roche Elecsys IgE II Assay serves as the comparative "reference" for patient samples. This predicate device itself is assumed to be traceable to international standards and validated.
• A priori defined analytical specifications: For precision, linearity, and detection limits, the "ground truth" or acceptance criteria are statistically derived technical specifications (e.g., CV limits, bias limits) that the device must meet to be considered analytically robust.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning or AI models because this is not an AI/ML-based device. It is a traditional in vitro diagnostic immunoassay. The performance studies detailed are validation studies for the cleared device.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the AI/ML sense for this traditional IVD product. If "training set" broadly refers to materials used during the development and calibration of the assay, the document indicates that the assay is traceable to the WHO 3rd International Standard 11/234, and a six-level lot-matched calibrator set is included, which would be used to establish the calibration curve for the assay.

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Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

The presented document is a 510(k) summary for the IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Calibrator, submitted by Beckman Coulter, Inc. It describes the device, its intended use, comparison to a predicate device, and a summary of performance data.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, r-value, or imprecision percentages. Instead, it presents the results of method comparison and imprecision studies as evidence of substantial equivalence to the predicate device. The implied acceptance is that the device's performance is comparable to or within expected variations for such assays, as demonstrated by the presented data.

Ask a specific question about this device