Search Results

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.

The provided text describes the ImmunoCAP Allergen Components, an in vitro quantitative assay for the measurement of allergen-specific IgE antibodies. The submission (K111919) covers the addition of 12 new ImmunoCAP Allergen Components to the existing ImmunoCAP Specific IgE assay.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the "Performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the immunological specificity of the allergen components."

However, specific numerical acceptance criteria (e.g., "precision must be X%) | Stated that inhibition studies verified immunological specificity. |
| Comparison to Predicate Devices | Agreement/correlation with extract-based predicate devices (specific thresholds not given). | Stated that new components were compared with extract-based predicate devices using clinical samples and healthy donors. |

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document states that performance characteristics were established using "clinical samples, as well as samples from healthy, nonatopic donors." However, no specific numerical sample size for the test set is provided.
• Data Provenance: The country of origin is not specified. Given that the manufacturer is Phadia AB (Sweden) and the distributor is Phadia US Inc. (USA), it's plausible the samples could be from either or both regions, but this is an inference, not a stated fact. The studies involved "clinical samples" suggesting they were from patients, and "healthy, nonatopic donors." The document doesn't explicitly state if the studies were retrospective or prospective.

3. Number of Experts and Qualifications:

The document does not mention using experts to establish ground truth for the test set. For IVD devices like this, ground truth is typically established through a combination of clinical diagnosis and comparison to established reference methods using the biological samples themselves.

4. Adjudication Method:

The document does not mention any adjudication method as it does not rely on expert interpretation of images or complex data that would necessitate such a process.

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

This type of study is not applicable to this device. An MRMC study typically involves human readers interpreting data (e.g., medical images) with and without AI assistance to measure improvements in diagnostic accuracy or efficiency. The ImmunoCAP Allergen Components are an automated in vitro quantitative assay, not an AI-assisted diagnostic imaging tool.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The entire "Performance characteristics" section describes the evaluation of the device itself (ImmunoCAP Allergen Components) in isolation to establish its precision, linearity, limit of detection, reproducibility, and immunological specificity. The system processes all steps automatically and prints results, indicating a standalone device without human-in-the-loop performance being part of the primary evaluation of the assay's core functionality.

7. Type of Ground Truth Used:

The ground truth for evaluating the performance of the ImmunoCAP Allergen Components would be derived from:

• Clinical Diagnosis: For the "clinical samples," the ground truth likely involves correlating the IgE levels to the patient's diagnosed IgE-mediated allergic disorders or lack thereof.
• Reference Methods/Clinical Status: For "healthy, nonatopic donors," the ground truth is their confirmed non-allergic status.
• Predicate Device Comparison: The document states the new components were "compared with the extract based predicate devices." This implies that the results from the predicate devices served as a form of reference or comparative ground truth to assess the performance of the new components.
• Immunological Specificity: For inhibition studies, the ground truth relates to the expected specific immunological reaction.

8. Sample Size for Training Set:

The document does not provide any information regarding a "training set." This terminology is more common in machine learning contexts. For an in vitro diagnostic assay like this, the development process might involve internal validation, but it's not typically described using "training set" in regulatory submissions. The emphasis is on the performance evaluation of the final product.

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

As no training set is mentioned, this information is not provided.

Ask a specific question about this device