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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 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 2500 and Phadia 5000 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.

The provided text describes a 510(k) submission for the ImmunoCAP Allergen i3, Common wasp venom (Yellow jacket) and ImmunoCAP Allergen i4, Paper wasp venom, which are in vitro quantitative assays. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific threshold values. Instead, it states that the performance characteristics were "established through studies of Precision, including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the immunological specificity of the allergens." The overall conclusion is that the updated devices demonstrate substantial equivalence to the currently cleared products.

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

• Sample Size for Test Set: The exact number of samples used in the comparison studies is not explicitly stated. It mentions "Positive samples from atopic donors, as well as samples from healthy, non-atopic donors were used in the study."
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.

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 "ground truth" for these types of assays typically refers to a reference method or clinical diagnosis of allergy, but the process of establishing this reference is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic device, and its performance is evaluated based on its ability to measure specific IgE antibodies, not on human reader interpretation of images or other data. The study involved comparing the updated device's performance to existing predicate devices.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are essentially a standalone performance evaluation of the ImmunoCAP assays. The "device" in this context is completely automated, processing all steps of the assay and printing results automatically. The performance characteristics (Precision, Lot-to-Lot Reproducibility, Linearity, Limit of Detection, Immunological Specificity) are inherent to the assay itself.

7. Type of Ground Truth Used

The ground truth implicitly used for the comparison studies involves samples from "atopic donors" (allergic) and "healthy, non-atopic donors." This suggests that the ground truth is clinical diagnosis of allergy, likely established through a combination of clinical findings, patient history, and potentially other diagnostic tests. The predicate devices themselves serve as a reference for performance comparison.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an AI-driven image analysis or diagnostic prediction tool that typically relies on training sets. The "training" for such a device would be its initial development and optimization, rather than a distinct training set in the AI sense.

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

As there is no explicit mention of a "training set" in the context of AI, this information is not applicable. The development and optimization of the immunoassay involves standard laboratory procedures and validation against known characteristics of the analytes (IgE antibodies).

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