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510(k) Data Aggregation
(90 days)
ImmunoCAP Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). 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 is to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
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, Phadia 2500 and Phadia 5000 instrument systems, associated software, processes all steps of the assay and calculates results and a 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 a 510(k) submission for new ImmunoCAP Allergen Components (rCan f 4 Dog, rCan f 6 Dog, rFel d 7 Cat) to an existing ImmunoCAP Specific IgE assay system. While it mentions performance characteristics studies, it does not provide a specific table of acceptance criteria or reported device performance for these new components. It primarily focuses on the regulatory submission and overall claims of performance.
However, based on the provided text, I can infer and summarize what information is available and what is missing regarding acceptance criteria and the study.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance (as described) |
|---|---|---|
| Clinical Agreement | Compared to extract-based predicate device with clinical positive samples. | New ImmunoCAP Allergen Components were "compared to the extract based predicate device with the use of clinical positive samples." The specific metrics, thresholds for agreement (e.g., % positive agreement, % negative agreement, kappa value), and actual results are not provided. |
| Specificity | Samples from healthy, non-atopic donors were studied. Inhibition studies verified analytical specificity. | "Inhibition studies verified the analytical specificity of the allergen components." The specific metrics, thresholds (e.g., % non-reactive in non-atopic individuals), and actual results are not provided. |
| Precision | Not explicitly stated. | "Analytical performance characteristics... established by Precision..." The specific metrics (e.g., %CV) and actual results are not provided. |
| Lot-to-Lot Reproducibility | Not explicitly stated. | "...Lot-to-Lot Reproducibility..." The specific metrics and actual results are not provided. |
| Linearity | Not explicitly stated. | "...Linearity..." The specific metrics and actual results are not provided. |
| Limit of Detection | Not explicitly stated. | "...Limit of Detection..." The specific metrics and actual results are not provided. |
| Stability | Not explicitly stated. | "...and Stability studies." The specific parameters and results are not provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: The exact sample size for the "clinical positive samples" and "samples from healthy, nonatopic donors" is not provided.
- Data Provenance: The country of origin is not provided. The studies appear to be retrospective in nature, as they involve testing existing samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not provided in the document. For immunoassays, ground truth is typically established by the clinical status of the patient (e.g., diagnosed allergy, physician assessment, other valid allergy tests) rather than expert review of images.
4. Adjudication method for the test set
This information is not applicable as it pertains to expert review of diagnostic results, which is not described for this type of immunoassay. The ground truth would be based on the clinical diagnosis or reference methods.
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
- MRMC Study: This is not applicable. The device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described studies (Precision, Reproducibility, Linearity, LOD, Stability, Clinical Comparison) all represent the standalone performance of the immunoassay system (device and instrument). There is no "human-in-the-loop" component for interpretation described beyond the overall clinical context for diagnosis.
7. The type of ground truth used
The ground truth for the clinical studies appears to be based on:
- Clinical Status: "clinical positive samples" imply patients with a diagnosed IgE-mediated allergic disorder related to the specific allergens.
- Absence of Allergy: "healthy, nonatopic donors" implies individuals without (or assumed to be without) IgE-mediated allergic disorders.
- Predicate Device Comparison: The new components were compared against an "extract based predicate device," which itself serves as a reference standard, implying its results are also part of the ground truth or a comparator for performance.
8. The sample size for the training set
This information is not applicable as the device is an immunoassay kit, not a machine learning or AI algorithm that requires a separate training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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