Search Results

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. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. 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 concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The provided FDA 510(k) clearance letter and summary for the NOVEOS Specific IgE (sIgE) Assay outlines the device's performance, but it does NOT describe "acceptance criteria" in an explicit, quantifiable manner that is typically found in a clinical study report. Instead, the document presents study results and compares them to a predicate device (ImmunoCAP Specific IgE) to demonstrate substantial equivalence, and also to clinical diagnosis of allergic status. The closest approximations to acceptance criteria are implicit in the performance metrics presented (e.g., target ranges for sensitivity, specificity, agreement, precision, linearity).

This device is an in vitro diagnostic (IVD) assay, not an AI/ML-based diagnostic imaging or analysis system. Therefore, the concepts of "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts," "adjudication method," and "training set ground truth establishment" do not directly apply in the same way they would for AI-powered diagnostic imaging devices. The "ground truth" for this IVD device is established through reference methods (Skin Prick Test, Oral Food Challenge, ImmunoCAP predicate device) or established clinical diagnosis.

Here's a breakdown of the information that is provided and how it relates to the requested points, with interpretations where necessary for IVD context:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria are not stated. However, the performance data presented effectively serves as the "reported device performance" that presumably met the FDA's requirements for substantial equivalence. I will present the key performance metrics from the document.

Key Performance Metrics (Implicit Acceptance Criteria)

2. Sample Sizes Used for the Test Set and Data Provenance

• Clinical Performance Study (Clinical Sensitivity & Specificity):

  • Sample Size: Ranges from 102 to 228 patients overall, depending on the specific allergen.
    • "Atopic" (positive) samples: 32 to 88 samples confirmed by skin-prick testing or oral food challenge.
    • "Non-Atopic" (negative) samples: 53 to 146 samples deemed negative by ImmunoCAP testing (result <0.35 kU/L).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study," which implies real-world patient samples. It's unclear if the study was retrospective or prospective, but the description of "confirmed by skin-prick testing or oral food challenge" suggests a direct clinical evaluation.

• Method Comparison to ImmunoCAP:

  • Sample Size: Ranges from 175 to 268 patient samples, depending on the specific allergen.
  • Data Provenance: Not explicitly stated (e.g., country of origin). These are "patient samples," implying clinical origins. Retrospective or prospective nature is not specified.

• Precision/Reproducibility:

  • Sample Size: 80-86 replicates per sample for within-laboratory precision (4-5 samples per allergen).
  • Sample Size: 50-240 replicates per sample for lot-to-lot imprecision (4 samples per allergen).

• Linearity:

  • Sample Size: Three sets of serially diluted human serum samples (low, mid, high concentration) for each allergen. Dilutions created up to 1/32.

3. Number of Experts and Qualifications for Ground Truth

For an IVD device like this, "experts" in the sense of radiologists interpreting images are not directly involved in setting the ground truth for the device's output. The ground truth is laboratory or clinical reference standards.

• Clinical Study Ground Truth: "Allergic status (atopic) was confirmed by skin-prick testing or oral food challenge, and the other 53 to 146 samples were deemed negative (non‐atopic) by ImmunoCAP testing (result <0.35 kU/L)."

  • Number of Experts: Not specified. Skin-prick testing and oral food challenges are clinical procedures typically performed and interpreted by allergists or clinicians skilled in allergy diagnosis. ImmunoCAP testing is a laboratory-based method.
  • Qualifications of Experts: Implied to be medical professionals (allergists/clinicians) and laboratory personnel capable of performing and interpreting these established diagnostic tests. No specific "years of experience" or board certifications are mentioned.

• Method Comparison Ground Truth: The ImmunoCAP Specific IgE Assay (K051218) is used as the comparative "ground truth." This is a legally marketed predicate device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for this type of IVD device. The ground truth is based on established clinical diagnostic procedures (skin-prick test, oral food challenge) and a comparative predicate laboratory assay (ImmunoCAP), not on multiple human interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. This device is an in vitro diagnostic assay that directly measures a biomarker in serum.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance

• Standalone Performance: The reported performance of the NOVEOS sIgE Assay (clinical sensitivity/specificity, agreement with ImmunoCAP, precision, linearity, etc.) is the standalone performance of the assay system. It operates automatically to measure allergen-specific IgE levels. There isn't a "human-in-the-loop" aspect to its direct output generation; it provides a quantitative result. The interpretation of that result for clinical diagnosis happens after the device provides its measurement, "in conjunction with other clinical findings."

7. Type of Ground Truth Used

• Clinical Study Ground Truth:

  • Clinical Diagnosis: Allergic status was confirmed by skin-prick testing or oral food challenge (for atopic individuals). These are considered definitive clinical methods for allergy diagnosis.
  • Predicate Device Result: Samples deemed non-atopic were confirmed by ImmunoCAP testing (result <0.35 kU/L).

• Method Comparison Study Ground Truth:

  • Predicate Device Result: The ImmunoCAP Specific IgE Assay results were used as the comparator.

8. Sample Size for the Training Set

• Training Set: This device is a quantitative in vitro diagnostic immunoassay, not a machine learning or AI algorithm in the traditional sense that requires distinct "training" datasets for model development. The development of such assays involves extensive analytical validation (e.g., reagent optimization, calibration curve establishment, linearity, precision) using various characterized samples and controls, but this is different from an AI model's "training set." The document describes various validation studies, but does not refer to a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable as described above. The assay's performance characteristics (e.g., calibration, measurement range) are established through a rigorous and well-defined analytical validation process, typically using reference materials, characterized control samples, and patient samples with known concentrations/statuses, rather than through ground truth established for an AI "training set." The calibrators are traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234, which serves as a fundamental "truth" reference for IgE measurement.

Ask a specific question about this device