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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Instrument System - Phadia 100. Phadia 250 and Phadia 1000 instruments with built-in software process all steps of the assay and print results automatically after the assay is completed.

ImmunoCAP Specific IgE, Test Principle: The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

The provided text describes a 510(k) submission for new ImmunoCAP Allergen Components and refers to the performance characteristics established in previous 510(k) submissions for the ImmunoCAP Specific IgE system. Therefore, the acceptance criteria and study details are largely summarized rather than exhaustively detailed for this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format for this 510(k) submission. Instead, it states that "The performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the immunological specificity of the allergen components."

The conclusion states: "The safety and effectiveness of the cleared device ImmunoCAP Specific IgE system for the determination of specific IgE antibodies have been established in previous 510(k) submissions." This implies that the new allergen components meet the same performance standards as the existing system.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that the new ImmunoCAP Allergen Components were compared with predicate devices using "clinical samples, as well as samples from healthy, nonatopic donors." Specific numbers for the sample size are not provided.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though "clinical samples" often implies retrospective use of existing samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The device is a laboratory assay measuring IgE antibodies; the "ground truth" for such assays typically refers to agreement with established methods or clinical diagnosis, not expert image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. Given it's a quantitative assay, adjudication in the sense of resolving conflicting interpretations is typically not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation where human readers are involved. This document describes an in vitro diagnostic (IVD) assay where the instrument provides quantitative results.

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

Yes, the performance described is inherently standalone, as it refers to the device and its components generating quantitative results without human-in-the-loop performance influencing the assay's measurement. The instruments (Phadia 100, Phadia 250, and Phadia 1000) process all steps and print results automatically.

7. The Type of Ground Truth Used

The "ground truth" for this type of in vitro diagnostic assay would be the actual concentration of allergen-specific IgE antibodies or correlation with clinical diagnosis of allergic disorders. The document implies that the performance was established by comparison with "extract based predicate devices" using "clinical samples" and "samples from healthy, nonatopic donors," suggesting a comparison against established methods and clinical status. More specific details on how this "ground truth" was rigorously defined are not present in this summary.

8. The Sample Size for the Training Set

The document describes premarket notification for new allergen components being added to an existing system. It does not mention a "training set" as would be relevant for machine learning algorithms. Performance characteristics were evaluated with "clinical samples" and "healthy, nonatopic donors" for the purpose of demonstrating substantial equivalence, not for training an algorithm. Therefore, no distinct training set sample size is provided.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an algorithm, this question is not applicable. The ground truth for evaluating the performance of the assay itself would be based on the established clinical or laboratory standards as mentioned in point 7.

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