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ImmunoCAP Rapid Inhalant Profile 1, part of the ImmunoCAP Rapid System, is an in vitro semi-quantitative assay for measurement of allergen specific IgE to ten inhalant allergens (house dust mite, cat, dog, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm) in heparinized human capillary whole blood, heparinized venous whole blood, or heparinized 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, licensed under CLIA to perform nonwaived assays.

ImmunoCAP Rapid System is a combination of lateral flow immunoassay reagents and instrument/software for semi-quantitative determination of antibodies or antigens in human capillary whole blood, heparinized venous whole blood or heparinized plasma.

ImmunoCAP Rapid System currently consists of the following:

• ImmunoCAP Rapid Inhalant Profile 1 a kit for measuring specific IgE antibody . levels to 10 inhalant allergens (house dust mite, cat epithelium and dander, dog dander, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm).
• · ImmunoCAP Rapid Reader an instrument for reading and scoring the test results.
• ImmunoCAP Rapid Reader Check Device an external positive and negative Reader . control for regular checks of instrument performance.
• ImmunoCAP Rapid QC 1 a kit containing external positive and negative specific IgE . system controls to be performed with recommended frequency.

The Phadia ImmunoCAP® Rapid System, specifically ImmunoCAP® Rapid Inhalant Profile 1, is an in vitro semi-quantitative assay for measuring allergen-specific IgE antibodies to ten inhalant allergens.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 245 donors were included in the comparison studies.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a Swedish company (Phadia AB) with a US distributor, the data likely comes from studies conducted to meet international regulatory standards. It's retrospective in the sense that samples were collected and then tested. The summary implies a controlled study rather than real-world retrospective data collection.

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

• This information is not provided in the summary. The "ground truth" for the test set is established by the Predicate Device (ImmunoCAP Specific IgE) results, which themselves are an established diagnostic method. The summary does not mention separate expert reconciliation or adjudication for defining the "true" IgE levels beyond what the predicate device provides.

4. Adjudication Method for the Test Set

• This information is not provided. The comparison is directly between the New Device and the Predicate Device. There is no mention of an external adjudication process for the test results.

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

• No, an MRMC comparative effectiveness study, in the sense of human readers interpreting findings with and without AI assistance, was not done. This device is a diagnostic assay that outputs a semi-quantitative class (1, 2, or 3) for specific IgE levels, not an image interpretation system.

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

• The performance described is essentially standalone performance for the device. The ImmunoCAP Rapid Reader is an instrument that "reads and scores the test results" as Class 1, 2, or 3. The studies assess the accuracy and consistency of this automated reading process against a predicate device, without involving human interpretation of the rapid test results influencing the final determination.

7. The Type of Ground Truth Used

• The ground truth for evaluating the ImmunoCAP Rapid System was established by the Predicate Device: ImmunoCAP® Specific IgE laboratory test. This predicate device is itself a legally marketed and established method for measuring allergen-specific IgE. Therefore, the "ground truth" is a benchmark against an accepted, existing diagnostic tool.

8. The Sample Size for the Training Set

• The document does not specify a separate training set. The "comparison studies" involving 245 donors are described as the performance testing for the device. For an in vitro diagnostic (IVD) assay like this, "training set" might not be defined in the same way as for AI/ML algorithms. The assay's parameters would have been developed and optimized during its R&D phase, but a distinct "training set" linked to this submission is not mentioned.

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

• Since a specific "training set" and its ground truth are not explicitly described in this summary, the method for establishing its ground truth is also not provided. The development and optimization of the assay would typically involve using samples with known IgE levels (often characterized by reference methods or validated predicate devices) to establish optimal reagent concentrations, reading algorithms, and cut-offs for the different classes.

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