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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.

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.

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 510(k) summary (K121156) describes the addition of four new ImmunoCAP Allergens to the existing ImmunoCAP Specific IgE assay, which is an in vitro quantitative assay for the measurement of allergen-specific IgE antibodies. The study conducted focuses on the performance characteristics of these newly added allergens (f236, f309, t212, t222).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical "acceptance criteria" in a typical table format for metrics like sensitivity, specificity, or accuracy. Instead, it describes "performance characteristics" that were evaluated. The study seems to aim at demonstrating that the new allergens perform comparably to the established ImmunoCAP Specific IgE system.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document mentions using "clinical positive samples, as well as samples from healthy, non-atopic donors." However, it does not specify the exact number of samples used for evaluating each new allergen or the overall test set.
• Data Provenance: Not explicitly stated (e.g., country of origin). The terms "clinical positive samples" suggest they are from patients, but whether they are retrospective or prospective is not mentioned.

3. Number of Experts and their Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth for the test set. For an in vitro diagnostic device measuring IgE levels, the "ground truth" would typically be derived from clinical diagnosis of allergy, often supported by clinical history, physical examination, and other diagnostic tests (e.g., skin prick tests, challenge tests) which are not detailed here in terms of expert involvement for this specific study.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Since expert involvement in establishing ground truth is not described, no adjudication method would be presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is an in vitro diagnostic device that quantifies allergen-specific IgE. MRMC studies are typically for image-based diagnostic aids where human readers interpret results, and the AI's effect on their performance is measured. This type of study is not relevant for an assay that produces quantitative numerical results.

6. Standalone (Algorithm Only) Performance Study

• Yes, indirectly. The study evaluates the "performance characteristics" of the ImmunoCAP Allergens themselves (precision, reproducibility, linearity, limit of detection, immunological specificity). This is inherently a standalone evaluation of the assay's performance, as it measures the device's ability to accurately quantify IgE without human intervention in the result interpretation process (beyond reading the numerical output). The device itself (ImmunoCAP Specific IgE system) is an automated in vitro quantitative assay.

7. Type of Ground Truth Used

• The ground truth for the "clinical positive samples" would implicitly be the clinical diagnosis of an IgE-mediated allergic disorder to the specific allergen, and for "healthy, non-atopic donors," the absence of such an allergy. The document states that the device 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." However, the specific method for establishing this clinical ground truth for the samples used in the study is not detailed.
• For characteristics like linearity and limit of detection, the ground truth would be established through analytical testing using known concentrations of IgE.

8. Sample Size for the Training Set

• The document does not provide information on a "training set" in the context of an algorithm or machine learning model. This device is an immunoassay, not a machine learning-based diagnostic. Therefore, the concept of a training set as understood in AI/ML is not directly applicable. The "performance characteristics" studies (precision, linearity, etc.) utilize samples to validate the assay's analytical performance.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As explained above, the device is an immunoassay, not an AI/ML model, so there is no training set in that sense. The "ground truth" for analytical validation (e.g., linearity, detection limit) would be based on expertly prepared samples with known analyte concentrations.

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UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. 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, as well as physician office laboratories.

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. The system includes reagents (Conjugate, Calibrators, Curve Controls, Specific IgE ImmunoCAP and Allergen ImmunoCAP Carriers, Development Kit, Washing Solution) and ImmunoCAP instruments with built-in software. The assay principle involves allergen coupled to ImmunoCAP reacting with specific IgE in the patient sample, followed by incubation with enzyme labeled antibodies against IgE. After washing, the bound complex is incubated with a developing agent, and the fluorescence of the eluate is measured. The fluorescence response is transformed to concentrations using a calibration curve. The modification is a minor change to the calibrator system to extend the technical measuring range below 0.35 kUx/l by adding a 0 kU/l Calibrator and removing the 50 kU/l Calibrator, keeping 6 calibrators in total (0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l).

Here's a breakdown of the acceptance criteria and the study details for the UniCAP Specific IgE device modification, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the sample size used for the test set.
• It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The study focuses on evaluating the modification of the calibrator system rather than clinical performance on patient samples in this specific filing.

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

This information is not provided in the document. The study described focuses on the technical performance of the device's calibration system, not on establishing a ground truth for clinical diagnosis of allergic disorders using expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a technical comparison of calibration curves and determination of Limit of Quantitation, not a study involving human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical modification and verification of the device's measurement range and calibration.

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

Yes, in a sense, a standalone evaluation was performed. The study focused on the technical performance of the changed calibrator system as implemented in the device, without involving human interpretation or interaction during the measurement process. The device's instrument system processes all steps and prints results automatically.

7. The Type of Ground Truth Used

The "ground truth" for this study was primarily:

• Comparison against the previous/current calibration curves to assess conformity.
• Adherence to established laboratory protocols for determining Limits of Detection and Quantitation (NCCLS document EP-17A), which serves as a technical standard for assessing the accuracy of the assay's lower measurement range.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The study is about a modification to the calibrator system of an existing in vitro diagnostic device. The "calibration" of the device itself uses ImmunoCAP Specific IgE Calibrators 0-100 (which were modified in this update to 0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l as the six points).

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

Given that this is a modification to an existing in vitro diagnostic assay and not an AI/machine learning device, the concept of a "training set ground truth" as it applies to AI is not directly relevant.

For the purpose of the device's operation, the "ground truth" for the calibrators is established by their known concentrations (e.g., 0, 0.35, 0.7, 3.5, 17.5, and 100 kU/l), which are presumably manufactured and certified to specific standards. These calibrators are used by the instrument's built-in software to create a calibration curve against which patient samples are measured.

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