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510(k) Data Aggregation
(357 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 d202, Allergen component rDer p 1, House dust mite, 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 IdE 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.
This document is a 510(k) Summary for an update to the ImmunoCAP Specific IgE assay, specifically for the Allergen d202, Allergen component rDer p 1, House dust mite. It replaces a native purified protein with a recombinant purified protein.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list acceptance criteria in a quantitative table format with corresponding reported performance for specific metrics. Instead, it states that "The verification studies performed demonstrate that the updated ImmunoCAP Allergen d202 is substantially equivalent to the currently cleared product." and that "The performance characteristics of the updated ImmunoCAP Allergen d202 were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the analytical specificity of the allergen component."
Therefore, based on the provided text, the inferred acceptance criteria are that the new recombinant allergen component performs comparably to the previously marketing native allergen component across key analytical performance characteristics.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Performance characteristics (Precision, Lot-to-Lot Reproducibility, Linearity, Limit of Detection) are comparable to the predicate device. | Performance characteristics (Precision including Lot-to-Lot Reproducibility, Linearity, and Limit of Detection) were established. The new device was compared with the predicate device using clinical positive samples and samples from healthy, non-atopic donors. |
| Analytical specificity of the allergen component is maintained. | Inhibition studies verified the analytical specificity of the allergen component. |
| Overall safety and effectiveness are maintained and the device remains substantially equivalent. | "The verification studies performed demonstrate that the updated ImmunoCAP Allergen d202 is substantially equivalent to the currently cleared product." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states that the new device was compared with the predicate device using "clinical positive samples, as well as samples from healthy, non-atopic donors." However, no specific number for the sample size is provided in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical positive samples" and "healthy, non-atopic donors," indicating human biological samples. It can be inferred to be retrospective or prospective clinical sample collection for the comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The device is a quantitative in vitro assay, and its performance would typically be evaluated against established quantitative laboratory methods or clinical diagnoses, rather than expert consensus on individual test results.
4. Adjudication method for the test set:
This information is not provided in the document. As an in vitro diagnostic device, the comparison would likely be between the new device's results and a reference method's results, with no explicit human adjudication of the test results themselves described in this summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically applies to imaging or diagnostic interpretation scenarios where multiple human readers are evaluating cases. This submission is for an in vitro diagnostic assay for allergen-specific IgE, which is a quantitative laboratory test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance study effectively evaluates standalone performance. As an in vitro diagnostic assay, the device itself provides a quantitative result. The performance characteristics (precision, linearity, limit of detection, and analytical specificity) are inherent to the assay and instrument system without direct human interpretation of the assay result itself. The clinical interpretation of the result in conjunction with other findings is human-in-the-loop, but the assay performance is standalone.
7. The type of ground truth used:
The ground truth is based on comparison to a legally marketed predicate device (the native ImmunoCAP Allergen d202) and established analytical performance characteristics. The "clinical positive samples" and "healthy, non-atopic donors" serve as sources for evaluating the device's ability to differentiate between these groups, with the predicate device serving as the reference for acceptable performance. The underlying "truth" for such an assay is the presence or absence of specific IgE, likely confirmed by a combination of clinical diagnosis and existing diagnostic methods.
8. The sample size for the training set:
The document does not provide information on a training set sample size. This submission is an update to an existing device, changing a raw material. The device uses established principles of antigen-antibody reactions for IgE detection. If there was any "training" in the context of an algorithm or model development, it would have been for the original ImmunoCAP Specific IgE system or for establishing the calibration curve. This summary focuses on the verification and validation of the change to the allergen component.
9. How the ground truth for the training set was established:
This information is not provided as there is no mention of a "training set" in the context of this specific update. For the overall ImmunoCAP Specific IgE system and its calibration, the ground truth would have been established through a rigorous process of standardizing IgE concentrations using international reference materials and a robust calibration curve development.
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