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510(k) Data Aggregation
(97 days)
For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.
The provided text details the analytical and clinical performance of the IMMULITE® 2000 3gAllergy™ Specific IgE Assay for several new allergens.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for precision, linearity, or specificity. Instead, it presents the results of these studies and concludes that the performance is "acceptable" or "compares well" to clinical documentation.
However, based on the conclusions drawn and the type of data presented, implicit acceptance criteria can be inferred from the reported performance. The clinical performance section, in particular, provides quantifiable results that the device is deemed to meet.
| Study Type | Acceptance Criteria (Implicit from conclusions and typical industry standards) | Reported Device Performance |
|---|---|---|
| Precision | Within-Run and Total CV% should be acceptably low for diagnostic assays. (Typically < 10-15% for diagnostic range, lower for higher concentrations). The study highlights acceptable precision performance in both low and high ends of the assay range. | Within-Run CV%: Ranges from 2.40% (Careless Weed, Positive #4) to 6.07% (Sunflower Seed, Positive #1).Total CV%: Ranges from 4.05% (Saltbush, Positive #2) to 9.82% (Sunflower Seed, Positive #1).(All detailed CVs are below 10%, indicating good precision.) |
| Linearity | Regression statistics (slope, intercept, R-value) should demonstrate a strong linear relationship (slope near 1, intercept near 0, tight 95% CIs) between observed and expected values. The study mentions demonstrating linearity at concentrations within assay limits. | Slope: Ranges from 0.961 (Cephalosporium acremonium) to 1.013 (Careless Weed). All slopes are very close to 1.Intercept: Ranges from -0.043 (Poplar) to 0.059 (Cephalosporium acremonium). All intercepts are close to 0.95% CI for Slope: All CIs for slope include or are very close to 1.95% CI for Intercept: All CIs for intercept include or are very close to 0. |
| Specificity (Inhibition) | Target % inhibition of 50% should be met, and inhibition should be concentration-dependent. The study explicitly states this as a target. | All allergens demonstrate concentration-dependent inhibition and met the target % inhibition of 50%. For example, Saltbush showed 59.89% inhibition at 0.2 mg/mL and 83.96% at 1 mg/mL. Sunflower Seed showed 46.77% at 0.2 mg/mL (close to 50%) and 94.53% at 1 mg/mL. |
| Clinical Performance (Agreement to Clinical Data) | Sensitivity, Specificity, and Overall Agreement should be acceptably high. The document presents these figures with confidence intervals. "IMMULITE® 2000 assay results compare well with clinical documentation." | Sensitivity: 46.7% (Lower Conf. 41%, Upper Conf. 52%)Specificity: 95.6% (Lower Conf. 94%, Upper Conf. 97%)Agreement: 80.4% (Lower Conf. 78%, Upper Conf. 83%) |
2. Sample Size Used for the Test Set and Data Provenance
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Test Set Sample Size:
- Precision: For each allergen, three positive samples and one negative sample were tested (with a fourth positive sample for Poplar and Careless Weed). Each sample was assayed in two aliquots per run, over 20 different days, across three allergen lots. This indicates a substantial number of individual measurements (e.g., 4 samples/allergen * 2 aliquots * 2 runs/day * 20 days = 320 measurements per allergen per lot for general precision, plus additional for Poplar/Careless Weed)
- Linearity: For each allergen, two samples were diluted in 2-fold serial dilutions to 5 levels (total 6 concentrations including neat). "N" values in the table are 8 or 12, likely representing the number of data points used in the regression analysis for each allergen.
- Specificity (Inhibition): A single serum sample or pool of sera was used, tested at 5 or 6 different inhibitor concentrations.
- Clinical Performance: A total of 928 samples were tested (289 from atopic patients, 639 from non-atopic individuals).
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Data Provenance: The document does not explicitly state the country of origin for the clinical data. The study describes "atopic patients with case histories of suspected clinical reactions" and "non-atopic individuals," suggesting real-world patient samples. It's a prospective collection of data for the purpose of the study, as it describes "demonstrated by testing samples..." and comparing results to "accompanying clinical information."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document does not specify the exact number of experts.
- Qualifications of Experts: The ground truth for the clinical performance study was established by "clinical data" including "case histories of suspected clinical reactions to the specific allergen or allergy group" and "documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This implies evaluation by clinical allergists or immunologists, though their specific titles or years of experience are not provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "ground truth" for the clinical study was established by "accompanying clinical information" and "documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This suggests that a medical diagnosis, likely by a single expert or a standard clinical practice, served as the ground truth rather than a multi-reader adjudication process for the specific study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This study focuses on the analytical and clinical performance of the automated assay itself, not on how human readers interact with or are augmented by AI. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes. The entire performance evaluation presented for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay is a standalone (algorithm only) performance study. The device is an automated in vitro diagnostic immunoassay, meaning it directly measures allergen-specific IgE levels in human serum using a machine, without a human-in-the-loop for interpretation of the assay's direct output. The results are quantitative measurements (kU/L) produced solely by the instrument.
7. Type of Ground Truth Used
- Analytical Studies (Precision, Linearity, Specificity): Ground truth was established through known concentrations, dilutions, or inhibition properties of the samples used, verified through established laboratory methods and controls.
- Clinical Performance Study: The ground truth was based on clinical data, specifically "documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity" and "case histories of suspected clinical reactions to the specific allergen or allergy group." This is a form of clinical diagnosis or outcomes data related to a patient's allergic status.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of in vitro diagnostic assay, particularly one based on immunoassay technology for detecting specific biomarkers, typically doesn't involve a machine learning "training set" in the way an AI image analysis algorithm would. The development of the assay reagents and protocols is based on scientific principles of immunology and chemistry, rather than iterative learning from a large dataset of patient samples to "train" an algorithm.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for a machine learning algorithm is mentioned or implied, the concept of establishing ground truth for a training set in this context does not apply. The development of this type of diagnostic assay relies on validating the chemical and biological reactions against known standards and clinically defined conditions over years of research and development inherent in immunoassay technology.
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