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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 1000, Phadia 2500 and Phadia 5000. 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.

Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

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.

This document is a 510(k) Summary for the ImmunoCAP Specific IgE, Allergen Component rAra h 6, Peanut device (K173726). It describes the device's indications for use and performance characteristics.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "The performance characteristics of the new ImmunoCAP Allergen Component was established through verification studies of Precision, Lot-to-Lot Reproducibility, Limit of Detection, and Stability. Inhibition studies verified the analytical specificity of the allergen component."

While specific numerical acceptance criteria and reported device performance for each of these verification studies are not provided in this summary, 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 submission covers the addition of a new ImmunoCAP Allergen Component to the existing ImmunoCAP Specific IgE assay." This implies that the new component met the necessary performance standards.

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

• Sample Size for Test Set: The document mentions "clinical samples, as well as samples from healthy, non-atopic donors" were used for comparison with the predicate device. However, the specific sample size for the test set is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The device is an in vitro diagnostic test, and ground truth would typically be established by clinical diagnosis and/or other established testing methods, rather than by human expert review of images, as might be the case for imaging AI.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The context of this question (e.g., 2+1, 3+1) typically relates to expert review of ambiguous cases, which is not described for this in vitro diagnostic device validation.

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

Not applicable. This device is an in vitro diagnostic assay, not an AI intended to assist human readers in interpreting medical images. Therefore, an MRMC study and
effect size for human reader improvement with AI assistance are not relevant.

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

Yes, in essence. The validation described is for the performance of the assay itself, which is a standalone measurement of allergen-specific IgE. The "ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE...to be used with instruments Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000." The performance characteristics (Precision, Lot-to-Lot Reproducibility, Limit of Detection, Stability, Analytical Specificity) are evaluated for the assay's ability to accurately measure IgE levels.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation would typically be:

• Clinical Diagnosis: "an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings."
• Predicate Device Comparison: The new component was "compared with the extract based predicate device with the use of clinical samples." This implies that the predicate device's results served as a comparative ground truth.
• Known Samples: The use of "samples from healthy, non-atopic donors" would provide a ground truth of low or negative IgE levels.
• Known Spikes/Concentrations: For precision, stability, and limit of detection studies, ground truth is established by using samples with known concentrations or by spiking known amounts of analyte.

8. The Sample Size for the Training Set

This document describes the validation of a new allergen component for an existing ImmunoCAP assay. These are chemical/biological assays, not AI algorithms that require a "training set" in the machine learning sense. Therefore, a training set size is not applicable/provided. The "training" here refers to the development and optimization of the assay's reagents and protocols.

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

Similar to point 8, the concept of a "training set" and establishing its ground truth in the context of machine learning does not directly apply to the development of this in vitro diagnostic assay. The development process would involve optimizing reagent formulations and reaction conditions, with "ground truth" reflecting the desired assay characteristics (e.g., specific binding, sensitivity, dynamic range) against known standards and clinically relevant samples.

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