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510(k) Data Aggregation
(91 days)
DPC's IMMULITE Latex-Specific IgE is designed for the semi-quantitative detection of IgE antibodies specific to latex allergen in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
IMMULITE Latex-Specific IgE is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer.
Acceptance Criteria and Study for IMMULITE® Latex-Specific IgE
This document outlines the acceptance criteria and the study performed to demonstrate the substantial equivalence of the IMMULITE® Latex-Specific IgE device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria for the IMMULITE® Latex-Specific IgE. Instead, it presents performance equivalence data against two predicate devices (AlaSTAT® Microplate Latex-Specific IgE Allergen system and AlaSTAT® EIA Latex-Specific IgE Allergen system) to establish substantial equivalence. Therefore, the "acceptance criteria" are implied by the reported performance of the predicate devices and the direct comparison performed.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported IMMULITE® Latex-Specific IgE Performance (vs. AlaSTAT® Microplate) | Reported IMMULITE® Latex-Specific IgE Performance (vs. AlaSTAT® EIA) |
|---|---|---|---|
| Total Agreement | Not explicitly stated, but expected to be high | 89.8% | 89.8% |
| Relative Sensitivity | Not explicitly stated, but expected to be high | 92.7% (95% CI: 82.4% - 98.0%) | 91.2% (95% CI: 80.7% - 97.1%) |
| Relative Specificity | Not explicitly stated, but expected to be high | 84.8% (95% CI: 68.1% - 94.9%) | 87.1% (95% CI: 70.2% - 96.4%) |
2. Sample Size and Data Provenance
- Sample Size for the test set:
- Eighty-eight (88) patient samples were used for the method comparison study.
- Data Provenance: The document does not explicitly state the country of origin of the data. It is highly likely the data was collected within the United States, given the context of a 510(k) submission to the FDA. The data is retrospective, as it refers to "specimens from eighty-eight patient samples were evalutated" (sic), indicating existing samples were used.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish the ground truth for the test set, nor does it provide their qualifications. The study compares the IMMULITE device against the AlaSTAT predicate devices, implying that the established results from the predicate devices served as a form of "ground truth" for comparison.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. It describes a direct comparison between the IMMULITE device and two predicate devices, with results being compared against those generated by the predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study focuses on the performance of an in vitro diagnostic device, not on human readers' interpretation with or without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance study was done. The performance data presented (Total Agreement, Relative Sensitivity, Relative Specificity) are for the IMMULITE® Latex-Specific IgE assay operating independently and being compared to the output of the predicate devices. This represents the algorithm's performance without direct human-in-the-loop interaction for the measurement itself, although human interpretation of the final result may follow.
7. Type of Ground Truth Used
The ground truth used was the results generated by the predicate devices, specifically:
- DPC's AlaSTAT® Microplate Latex-Specific IgE Allergen system
- DPC's AlaSTAT® EIA Latex-Specific IgE Allergen system
These predicate devices are established methods for the detection of IgE antibodies specific to latex allergen.
8. Sample Size for the Training Set
The document does not specify the sample size for a training set. This is a clinical validation study for an in vitro diagnostic device, and not a machine learning algorithm that typically requires distinct training and test sets in the same way. The development and calibration of the IMMULITE assay would have involved various internal studies, but those are not described as a "training set" in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is described in the context of machine learning, the establishment of its ground truth is not applicable here. The inherent "ground truth" for the development of any diagnostic assay like the IMMULITE would stem from established scientific and clinical understanding of IgE-mediated allergic reactions to latex, validated reagents, and internal quality control processes.
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