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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, Phadia 1000, Phadia 2500, 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 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.

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

Acceptance Criteria and Device Performance Study

The provided document describes the submission of new ImmunoCAP Allergen Components to be added to an existing ImmunoCAP Specific IgE assay, a quantitative in vitro assay for measuring allergen-specific IgE antibodies. The submission asserts that the safety and effectiveness of the cleared device ImmunoCAP Specific IgE system have already been established in previous 510(k) submissions. This current submission focuses on demonstrating that the new allergen components maintain the performance characteristics of the established system.

The "acceptance criteria" are implied by the nature of the performance characteristics studied, which are typical for in vitro diagnostic devices. Since the device is an in vitro quantitative assay and the new components are additions to an existing system, the acceptance criteria would revolve around ensuring these new components perform similarly and reliably to established ones.

No explicit table of acceptance criteria with numerical targets is provided. Instead, the document states that performance characteristics were "established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the analytical specificity of the allergen components." The reported device performance is that these studies were conducted and the conclusion drawn is that the new components are suitable additions to the existing assay.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical values for precision, linearity, LoD, or the results of the comparative study. It only states that these studies were performed and that the new components are acceptable.

2. Sample Size and Data Provenance

• Sample Size for the test set: Not explicitly stated. The document mentions "clinical samples, as well as samples from healthy, nonatopic donors" were used for comparison with predicate devices. The exact number of samples for each type is not provided.
• Data Provenance: Not explicitly stated. Given that Phadia AB is located in Sweden and Phadia US Inc. is the distributor, it's possible the clinical samples originated from either country or other regions. The document does not specify whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement. The ground truth for such devices is typically established through analytical methods, reference standards, and correlation with clinical diagnoses, not usually through a panel of human expert readers adjudicating images or cases in the same way as an AI-powered image analysis system would.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring specific IgE levels, there isn't a "test set" in the context of human expert adjudication. The comparison was against established extract-based predicate devices using clinical and non-atopic samples.

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

Not applicable. This is an in vitro diagnostic device, not an AI-powered image analysis system or a decision support system that involves human readers interpreting results in an MRMC study setup.

6. Standalone (Algorithm Only) Performance

Yes, in a sense. The ImmunoCAP Specific IgE system (including these new components) is an automated quantitative assay. Its performance is evaluated independently of human interpretation of the raw reaction directly. The "algorithm" here refers to the instrument's processing of results and calculation of concentrations based on a calibration curve. The studies on precision, linearity, LoD, and analytical specificity assess this standalone performance of the assay itself.

7. Type of Ground Truth Used

For the analytical performance studies (precision, linearity, LoD, specificity), the ground truth is established using:

• Reference materials/standards: For linearity and LoD, known concentrations of IgE antibodies or spiked samples would typically serve as the ground truth.
• Established analytical methods: For specificity, the ability to selectively detect the target allergen is the ground truth.
• Clinical correlation: While not explicitly detailed for the new components, the overall ImmunoCAP Specific IgE assay is intended "as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings." This implies a connection to clinical outcomes or diagnoses for the broader system. For the comparative study, the performance of the extract-based predicate devices served as a comparative reference.

8. Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic assay. It does not use a "training set" in the context of machine learning algorithms. The "training" in this context would refer to the development and optimization of the assay reagents and protocols, which is a laboratory R&D process, not a machine learning training process with a distinct "training set."

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

Not applicable, as there is no "training set" in the machine learning sense. The assay development process involves analytical validation using standards and reference materials to ensure the assay accurately measures the target analyte.

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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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