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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 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 Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum and 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. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

The general ImmunoCAP reagents include ImmunoCAP Specific or Total IgE Conjugate, ImmunoCAP Specific or Total IgE Curve Control, ImmunoCAP Specific or Total IgE Calibrators, Specific or Total IgE anti-IgE, Allergen ImmunoCAP carriers (only for determination of Specific IgE), Development solution, Stop Solution and Washing Solution. The method specific reagents consist of individual purified allergen (native or recombinant), covalently coupled to a support in a plastic housing (only for determination of Specific IgE).

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 document describes the ImmunoCAP Specific IgE Assay and ImmunoCAP Total IgE Assay, which are in vitro quantitative assays for measuring allergen-specific and total IgE in human serum or plasma. The primary purpose of this 510(k) submission is to introduce a new Reference Material for the standardization of these assays.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list a table of acceptance criteria with corresponding device performance for the ImmunoCAP Specific IgE Assay and ImmunoCAP Total IgE Assay. The submission is focused on a change in the reference material and proving substantial equivalence to previously cleared devices.

However, the "Conclusion" section (page 6) states: "The safety and effectiveness of the cleared ImmunoCAP Specific and Total IgE systems, intended for the determination of specific and total IgE antibodies, have been established in previous 510(k) submissions. The Reference Material change does not affect the Intended Use or the Indications for Use statements, the fundamental scientific technology, specifications or manufacturing methods of the assays. The verification studies performed demonstrate that the updated ImmunoCAP Specific and Total IgE assays are substantially equivalent to the currently cleared products."

This implies that the acceptance criteria for these assays were established and met in prior 510(k) submissions, and the current submission aims to demonstrate that changing the reference material does not negatively impact the performance against those pre-established criteria. The specific performance metrics themselves (e.g., precision, accuracy, linearity) are not detailed in this document for the current change.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions two studies conducted to evaluate the impact of the new reference material:

• "Concentration determination of two stock solutions used for production of ImmunoCAP Specific IgE Calibrators"
• "Evaluation of clinical negative and positive patient samples in ImmunoCAP Specific IgE"

Sample Size: The exact sample sizes for these studies are not provided in this document.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies involve laboratory-based comparisons of calibration and patient samples, rather than subjective interpretation by experts. The "ground truth" here would relate to the accurate measurement of IgE concentration, which is assessed through reference materials and comparative analysis with previously established methods, not expert consensus in the same way it would be for imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where multiple human readers or experts are involved in interpreting results which are then subject to a consensus process. The studies described are laboratory-based assays comparing different versions of a product.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging diagnostics or other AI-assisted diagnostic tools where human interpretation is a key component. The ImmunoCAP assays are in vitro diagnostic tests that produce quantitative results, not interpretations by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The ImmunoCAP assays are inherently "standalone" in the sense that they are laboratory tests that generate quantitative results automatically using instruments (Phadia 100, 1000, 2500, 5000) and associated software after the assay procedure. There isn't a human-in-the-loop performance component in the measurement itself, though clinical interpretation of the quantitative results by a healthcare professional is part of their intended use. The performance characteristics would be assessed based on the accuracy and precision of the system's measurements. The document implies laboratory "verification studies" were performed to compare the new device to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the ImmunoCAP assays, as indicated by the "Description of change" (page 6), is linked to international standards for serum IgE. Specifically, the new Reference Material is traceable to the 3rd WHO International Standard (300 WHO IRR) for serum IgE (11/234), replacing the 2nd WHO IRR. This means the accuracy of the device's measurements is evaluated against these established international biological reference standards.

8. The sample size for the training set

This information is not provided in the document. For in vitro diagnostic assays, "training set" is not a standard term in the same way it is for machine learning algorithms. The development and calibration of such assays typically involve optimizing reagents and protocols using a range of known standards and samples, but these are not explicitly referred to as "training sets."

9. How the ground truth for the training set was established

As noted in point 8, the concept of a "training set" with established ground truth is not explicitly addressed in the document in the context of algorithm development. However, the calibration and standardization of the ImmunoCAP assays rely on established WHO International Standards for serum IgE. These standards themselves are developed through extensive collaborative studies involving numerous laboratories and experts to assign specific IgE concentration units, thereby serving as the "ground truth" reference for calibration and measurement accuracy.

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