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510(k) Data Aggregation
(155 days)
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 Allergen w1, Common ragweed, is part of ImmunoCAP Specific IgE assay system. ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform 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 associated software process all steps of the assay and calculate 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 current submission describes a change of this allergen reagent due to naturally increased amounts of the major allergen component Amb a 1 in ragweed pollen.
No changes of Intended Use/Indications for Use or fundamental scientific technology of the assay system, or any other reagents of the system, instruments or software, have been made due to the update of ImmunoCAP Allergen w1, Common ragweed.
The provided text describes an ImmunoCAP Allergen w1, Common ragweed device, which is an in vitro quantitative assay for measuring allergen-specific IgE. The document details a 510(k) submission for an updated version of this allergen reagent.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Key Takeaway: The submission is for an update to an existing device (ImmunoCAP Allergen w1, Common ragweed) due to a naturally increased amount of the major allergen component Amb a 1 in ragweed pollen. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that this updated version is substantially equivalent to the previously cleared product, and that the changes do not negatively impact safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a typical table format with specific thresholds for sensitivity, specificity, accuracy, etc., that a novel device might present. Instead, for this update, the acceptance criteria are implicitly tied to demonstrating equivalence and maintaining performance characteristics compared to the predicate device.
| Acceptance Criteria (Inferred from study description) | Reported Device Performance (Updated Allergen w1 vs. Current Allergen w1) |
|---|---|
| Maintain Analytical Performance: | Precision: Established through verification studies. |
| - Precision | Lot-to-lot Reproducibility: Established through verification studies. |
| - Lot-to-lot reproducibility | Limit of Detection/Quantitation (LoD/LoQ): LoQ remains unchanged. |
| - Limit of Detection / Quantitation | Linearity: Established through verification studies. |
| - Linearity | Analytical Specificity: Verified through inhibition studies. |
| - Analytical Specificity | |
| Consistent Biological Response (for negative samples): | Negative samples with the current product remain negative with the updated product, with no change in background level. |
| Increased IgE detection (for positive samples): | Obtained concentrations of specific IgE antibodies in w1 positive samples are increased approximately two times with the updated ImmunoCAP Allergen w1, compared to the current ImmunoCAP Allergen w1. This is attributed to a "better performing product containing higher amounts of the major allergen component Amb a 1." |
| No significant impact on clinical performance for low-level positives: | Expected that some samples just below 0.1 kU/L (not detected by current product) will become analytically positive. However, this is expected to have "little impact on the clinical performance of the product in a general population of w1 allergic patients" due to the rarity of such very low samples. |
| No change to Intended Use/Indications for Use: | No changes to Intended Use/Indications for Use or fundamental scientific technology. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: "clinical positive samples, as well as samples from healthy, non-atopic donors." The exact number of samples is not specified in the provided text.
- Data Provenance: The text does not specify the country of origin. It can be inferred that samples would be human serum or plasma. It does not state whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not provide information regarding experts used to establish ground truth or their qualifications. Given that this is an in vitro diagnostic device measuring biomarkers, the "ground truth" would likely be established empirically through laboratory testing and correlation with clinical status (e.g., diagnosed allergic patients vs. healthy controls), rather than expert consensus on images or interpretations.
4. Adjudication method for the test set
The provided text does not specify any adjudication method. This is typical for a quantitative in vitro diagnostic device where sample results are typically compared to established thresholds or predicate device results, rather than requiring expert judgment for each test result in the same way as an imaging or diagnostic AI interpretation.
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
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here as the device is an in vitro quantitative assay for biomarker measurement, not an AI or imaging diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The ImmunoCAP system operates as an automated standalone system for measuring IgE levels. The "algorithm" here refers to the instrument's processing and calculation steps. The "performance characteristics" studies (precision, reproducibility, LoD/LoQ, linearity, analytical specificity) are inherently standalone performance evaluations of the device itself.
7. The type of ground truth used
The ground truth is implied to be based on:
- Clinical Diagnosis: "clinical positive samples" and "healthy, non-atopic donors" suggest that samples were obtained from individuals with a known clinical status regarding ragweed allergy.
- Predicate Device Performance: The primary comparison is against the "current ImmunoCAP Allergen w1," which serves as a established reference for performance, implying its results are considered the existing "ground truth" for what to expect.
8. The sample size for the training set
The provided text does not mention a training set for the device. This is because the ImmunoCAP system is a laboratory assay with established biochemical principles, not a machine learning model that typically requires a large training set. The "update" refers to a change in the biological reagent (allergen extract), not an AI algorithm.
9. How the ground truth for the training set was established
Since no training set is mentioned (as explained in point 8), this question is not applicable.
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