Search Results

ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or 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, as well as physician office laboratories.

The safety and effectiveness of the cleared device ImmunoCAP Specific IgE system for the determination of specific IgE antibodies have been established in previous 510(k) submissions. This submission covers the addition of a new allergen ImmunoCAP Allergen d201, House dust mite (Blomia tropicalis) to the existing ImmunoCAP Specific IgE assay. No changes are made to the Intended Use or in the Indications for Use statements.

The new ImmunoCAP Allergen d201, House dust mite was characterized with the use of clinical and positive samples, as well as samples from healthy, non-atopic donors. Inhibition studies verified the immunological specificity of Blomia tropicalis specific IgE antibody binding.

The provided text describes the ImmunoCAP Allergen d201, House dust mite (Blomia tropicalis) device, which is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. It falls under the existing ImmunoCAP Specific IgE assay system.

However, the provided text does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test and training sets, or information on expert involvement (number, qualifications, adjudication) as requested.

The summary states: "The new ImmunoCAP Allergen d201, House dust mite was characterized with the use of clinical and positive samples, as well as samples from healthy, non-atopic donors. Inhibition studies verified the immunological specificity of Blomia tropicalis specific IgE antibody binding." This is a very brief statement of the study conducted, without the detailed information required to answer most of your questions.

Therefore, many of the requested fields cannot be filled from the given document.

Here's an attempt to answer based on the limited information available in the provided text:

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

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "clinical and positive samples, as well as samples from healthy, non-atopic donors."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

This device is an automated in vitro diagnostic assay (measurement of IgE antibodies), not an imaging-based AI diagnostic system that would typically involve human readers interpreting results in the way an MRMC study evaluates. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable to this type of device.

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

Yes, the device (ImmunoCAP Specific IgE assay with Allergen d201) operates as a standalone automated assay. The "ImmunoCAP 100°, ImmunoCAP 250 and ImmunoCAP 1000 instruments with built-in software process all steps of the assay and print results automatically after the assay is completed." The "new ImmunoCAP Allergen d201, House dust mite was characterized with the use of clinical and positive samples, as well as samples from healthy, non-atopic donors." This implies the performance of the assay itself.

7. The type of ground truth used

"Clinical and positive samples, as well as samples from healthy, non-atopic donors" were used. This suggests that the ground truth was based on clinical diagnosis/status (i.e., whether individuals were known to be allergic to Blomia tropicalis, or healthy/non-atopic controls). "Inhibition studies verified the immunological specificity" also points to laboratory-based validation of the assay's ability to detect the specific IgE antibodies for Blomia tropicalis.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document only mentions characterization studies using various sample types. The concept of a separate "training set" for an algorithm in the machine learning sense is not explicitly discussed, as this is an immunoassay rather than a deep learning model.

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

Not explicitly detailed as a separate "training set." The characterization used "clinical and positive samples, as well as samples from healthy, non-atopic donors." This implies that the ground truth for these samples was established through known clinical status or other diagnostic methods that identified individuals as allergic to Blomia tropicalis or as non-allergic controls.

Ask a specific question about this device