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510(k) Data Aggregation
(257 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 250. 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 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 instruments with built-in software process all steps of the assay and print 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ImmunoCAP Allergen k82, Latex device:
Acceptance Criteria and Study for ImmunoCAP Allergen k82, Latex (K121463)
The provided document describes the 510(k) submission for an updated version of the ImmunoCAP Allergen k82, Latex. The primary "study" described is a comparison study against the previously cleared ImmunoCAP Allergen k82, Latex, to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in a typical table format for performance metrics like sensitivity, specificity, or accuracy. Instead, it details that the updated device was verified against its predecessor through a comparison study and that performance characteristics were established.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | To be substantially equivalent to the currently cleared ImmunoCAP Allergen k82, Latex (K972068). | The data demonstrated that the updated ImmunoCAP Allergen k82, Latex is substantially equivalent to the current product. |
| Precision | Not explicitly stated; likely within acceptable manufacturing/assay variability compared to the predicate. | Performance characteristics were established through studies of Precision, including Lot-to-Lot Reproducibility. |
| Lot-to-Lot Reproducibility | Not explicitly stated; likely acceptable variability. | Performance characteristics were established through studies of Lot-to-Lot Reproducibility. |
| Linearity | Not explicitly stated; likely within acceptable range. | Performance characteristics were established through studies of Linearity. |
| Limit of Detection | Not explicitly stated; likely comparable to or better than the predicate. | Performance characteristics were established through studies of Limit of Detection. |
| Immunological Specificity | Inhibition studies should confirm immunological specificity. | Inhibition studies verified the immunological specificity of the allergen. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document states: "Clinical positive samples, as well as samples from healthy, non-atopic donors were used in the study." However, it does not specify the exact number of samples (sample size) used for either the positive or healthy/non-atopic groups.
- Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the term "comparison study" with clinical samples and healthy donors suggests it was likely a prospective collection or at least a concurrent execution of tests on pre-existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the test set. For an in vitro diagnostic (IVD) like this, ground truth is typically established by comparing the device's results to a reference method, clinical diagnosis (though "clinical positive samples" are mentioned), or other established laboratory tests, rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method. This type of IVD performance study typically compares analytical results against a reference method or clinical status, rather than involving expert review and adjudication in the way image-based diagnostics might.
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 is more relevant for diagnostic imaging interpretation where multiple human readers assess cases, and the document describes an in vitro assay for biomarker measurement. The study focuses on the analytical performance of the ImmunoCAP system itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study of the ImmunoCAP Allergen k82, Latex assay. The device is an automated in vitro quantitative assay and its performance characteristics (precision, linearity, limit of detection, and specificity) were established directly. There is no "human-in-the-loop" component described for its core function or performance evaluation.
7. The Type of Ground Truth Used
The ground truth was established by classifying samples as "Clinical positive samples" and "samples from healthy, non-atopic donors." This implies that the ground truth for the test set was based on clinical diagnosis/status (for positive samples) and known healthy status (for negative samples), likely confirmed by other clinical findings or existing diagnostic methods. It's not pathology, expert consensus (in the sense of independent review), or solely outcomes data, but rather a categorized clinical status.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This is typical for an IVD device unless a machine learning or AI algorithm requires an explicit training phase during its development (which is not described here, as the device principle is a standard immunoassay). The "calibration curve" mentioned implies the use of calibrators within each assay run, which are distinct from a general "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned outside of the calibrators for assay operation, there is no information on how ground truth for a training set was established. For the assay's operational calibration, the ground truth (concentration values) would be established by the manufacturer through rigorous analytical characterization of the calibrator materials.
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