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510(k) Data Aggregation
(55 days)
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
The NOVEOS™ Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
The provided document describes the analytical and clinical performance of the NOVEOS Specific IgE (sIgE) Assay for Dermatophagoides farinae (D002), an in vitro diagnostic device. It does not describe a study involving human readers assisting with AI, but rather a laboratory-based immunoassay. Therefore, information related to "Number of experts used to establish the ground truth for the test set," "Adjudication method," and "MRMC comparative effectiveness study" is not applicable for this type of device and study.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an in vitro diagnostic assay, typical acceptance criteria would involve analytical performance metrics like accuracy (compared to a predicate or clinical diagnosis), precision (reproducibility), linearity, detection limits, and interference. The document presents these results rather than explicit "acceptance criteria" tables. However, we can infer the implicit criteria from the reported data.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred from study design/results) | Reported Device Performance (NOVEOS sIgE, D002) |
|---|---|---|
| Accuracy (vs. Predicate) | High percent agreement with legally marketed predicate device (ImmunoCAP d2). | Total Percent Agreement (TPA): 97.4% (95% CI: 94.5% to 98.8%) Positive Percent Agreement (PPA): 94.1% (95% CI: 87.8% to 97.3%) Negative Percent Agreement (NPA): 100.0% (95% CI: 97.2% to 100.0%) (Compared to ImmunoCAP d2 using a 0.35 kU/L cutoff) |
| Clinical Performance | Clinically acceptable sensitivity and specificity against clinical diagnosis. | Clinical Sensitivity: 77.3% (95% CI 66.7% to 85.3%) Clinical Specificity: 100.0% (95% CI 96.7% to 100.0%) (Compared to clinical diagnosis confirmed by skin-prick testing and clinical history, using a 0.35 kU/L cutoff) |
| Imprecision/Reproducibility | Low coefficient of variation (CV%) for within-run, between-run, between-day, lot-to-lot, and site-to-site measurements across different IgE concentrations. | Within-Run CV%: 3.20% - 8.40% (for individual samples) Total Imprecision CV%: 5.50% - 10.00% (for individual samples) Lot-to-Lot Total CV%: 9.9% - 14.5% (for individual samples) Site-to-Site Reproducibility CV%: 5.7% - 11.6% (for individual samples) |
| Linearity | Measured values should exhibit a strong linear relationship with expected values across the assay range. | Regression Equation: y=1.00x + 0.47 Slope (95% CI): 0.99-1.01 Intercept (95% CI): -0.90 to -0.05 R2: 1.000 (Over a dilution range of 0.04-126.49 kU/L, encompassing the measuring interval of 0.10 to 100 kU/L) |
| Interference | Minimal interference (< 10%) from common endogenous and exogenous substances. | <10% interference with: - Hemoglobin (200 mg/dL) - Conjugated Bilirubin (30 mg/dL) - Unconjugated Bilirubin (20 mg/dL) - Lipemia (3000 mg/mL) - Biotin (1200 µg/L) - Diphenhydramine (19.6 µmol/L) - Methylprednisolone (1000 ng/mL) - Ranitidine (19.1 µmol/L) - Omalizumab (0.12 mg/mL) - Human Serum Albumin (120 mg/mL) - Rheumatoid Factor (513 IU/mL) |
| Cross-Reactivity | Non-detectable cross-reactivity with other human immunoglobulins and specific inhibition patterns for related/unrelated allergens. | Non-detectable with physiological concentrations of IgA, IgD, IgM, IgG. <15% inhibition to D002 for related (D070) and unrelated (F001, G006, W003) allergens. |
| Detection Limits | Clearly defined and acceptable LoB, LoD, and LoQ. | LoB: 0.03 kU/L LoD: 0.05 kU/L LoQ: 0.17 kU/L (20%CV within-lab precision) |
| Reference Range | Consistent with expected values in a healthy population. | All 128 apparently healthy subjects tested below <0.35 kU/L. Expected value for non-atopic person is negative (<0.35 kU/L). |
| Stability | Demonstrated shelf-life and on-board stability for various components. | Shelf-life stability (unopened, 2-8°C): 18-48 months (accelerated data), 8 months (real-time ongoing). Specific components vary (e.g., D002 Reagent: 24 months, Conjugate IgE: 18 months). On-board stability: 48 hours to 28 days for various components (e.g., D002 Reagent: 28 days, Calibrator Set: 48 hours). |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy (vs. Predicate): 234 samples (including 97 skin prick test positive samples). The provenance of these samples (country of origin, retrospective/prospective) is not explicitly stated, but they are implied to be clinical samples used for comparison.
- Clinical Performance: 187 samples (75 with allergic status confirmed by skin-prick testing and clinical history, 112 from healthy, non-atopic donors with no reported allergy). The provenance is not explicitly stated.
- Imprecision/Reproducibility:
- Repeatability and within-laboratory precision: Samples assayed in duplicate in 2 runs per day for 20 days on 3 NOVEOS Immunoassay Analyzers (total of 80 replicates per sample evaluated for 7 different samples/controls).
- Lot-to-lot imprecision: 8 serum samples (3 negative, 5 positive) tested in 2 replicates per run, 2 runs per day for 20 days (total of 240 replicates per sample) using 3 different reagent lots.
- Site-to-site reproducibility: 4 patient pools and 2 controls tested in 5 replicates per run, 1 run per day for 5 days on 1 analyzer at each of 3 sites (total of 75 replicates per sample).
- Linearity: Samples with IgE concentrations from 0.04 to 126 kU/L were used. Number of distinct samples or dilution points not specified, but the range is.
- Interference & Cross-Reactivity: Not directly stated, but typically involves a panel of samples spiked with interfering substances or related analytes.
- Detection Limit: 90 replicates of analyte-free samples and 300 replicates of low IgE samples for LoB/LoD. For LoQ, low analyte samples assayed in replicates of five in 2 runs per day for 5 days (50 replicates total).
- Reference Range: 128 apparently healthy subjects.
The studies are described as analytical and clinical performance studies, implying they are a form of prospective data collection for regulatory submission. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this in vitro diagnostic assay. The ground truth for clinical performance was established by "skin-prick testing and clinical history" for allergic status and "healthy, non-atopic donors with no reported allergy" for non-allergic status. These data are typically generated by allergists or clinicians, but the number and qualifications of those individuals are not specified.
4. Adjudication Method for the Test Set
Not applicable. This is not an image-based diagnosis or a study requiring human readers to adjudicate results. The device's results are quantitative and compared against established methods or clinical status.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this was not an MRMC study. This device is an automated laboratory immunoassay for quantitative measurement of IgE, not an AI assisting human readers with interpreting images or other data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are all standalone performance evaluations of the NOVEOS Specific IgE Assay system. It is an automated in vitro diagnostic device, and its performance is assessed intrinsically, independent of human interpretive assistance during the measurement process. Human involvement occurs in sample collection and result interpretation in clinical context, but not in assisting the device's measurement.
7. The Type of Ground Truth Used
- For Accuracy (vs. Predicate): The "ground truth" was established by comparison with a legally marketed predicate device (ImmunoCAP d2) using a consistent cutoff value (0.35 kU/L).
- For Clinical Performance: The "ground truth" for allergic status was based on clinical diagnosis confirmed by skin-prick testing and clinical history for the allergic group, and "healthy, non-atopic donors with no reported allergy" for the non-atopic group. This represents a form of outcomes data/clinical findings consensus.
- For Analytical Performance (Precision, Linearity, Detection Limits, Interference, Cross-Reactivity): Ground truth is typically established by reference methods, gravimetric dilutions, or known concentrations of analytes/interferents. These are standard laboratory practices for validating assay performance.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an machine learning or AI algorithm. This device is a quantitative immunoassay, not a machine learning model that needs training on data in the same way. Its parameters and calibration are established through standard assay development and validation protocols, which involve titrations, optimization, and establishment of calibration curves during the manufacturing process.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" and associated "ground truth" for an AI model is not directly applicable to this traditional immunoassay device. The device's operational characteristics (e.g., calibration curve, reagent concentrations, reaction times) are determined through laboratory development and optimization, rather than machine learning training on a distinct dataset with "ground truth labels". The reference standard used for calibration is the "World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234," which serves as the traceability standard for quantitative measurements.
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