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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/co-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.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Description of Device: The IMMULITE® 2000 3gAllergy™ Specific IgE Assay is a solid-phase, two-step, chemiluminescent immunoassay for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. This submission focuses on clearance for eleven additional specific allergens.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for precision, linearity, or inhibition (specificity). Instead, the studies demonstrate the performance and imply that the results obtained are considered acceptable for a device of this type. The table below summarizes the reported performance for each study.

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

• Precision Test Set:

  • For each of the 11 allergens, three positive samples and one negative sample were used. These were assayed in two aliquots per run, across two runs per day, for 20 different days.
  • Provenance: Not specified, but generally, such studies are conducted in-house by the manufacturer.
  • Retrospective/Prospective: Prospective, as it involved controlled experimental conditions.

• Linearity Test Set:

  • For each allergen, two samples were diluted into 5 levels (undiluted + 4 serial dilutions).
  • Provenance: Not specified, likely internal.
  • Retrospective/Prospective: Prospective.

• Specificity (Inhibition) Test Set:

  • A single serum sample or a pool of sera was used for each allergen against a relevant inhibitor extract. A negative sample was also used to measure background response.
  • Provenance: Not specified, likely internal.
  • Retrospective/Prospective: Prospective.

• Clinical Studies Test Set:

  • Total N: 1,957 samples
  • Composition: Samples from "non-atopic individuals" and "atopic patients with case histories of suspected clinical reactions to the specific allergen or allergy group."
  • Provenance: Not specified (e.g., country of origin). The mention of "clinical data" suggests real-world patient samples.
  • Retrospective/Prospective: Not explicitly stated, but the comparison to "case histories" and clinical documentation suggests a retrospective analysis of collected samples with known clinical status.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Precision, Linearity, Specificity: These are analytical performance studies and do not rely on expert ground truth in the same way clinical studies do. The ground truth for these is established by the known concentrations (linearity), or the inherent characteristics of the samples and inhibitors (specificity, precision) as determined by laboratory methods. No external experts are mentioned for establishing ground truth for these analytical tests.

• Clinical Studies:

  • The ground truth for the clinical study was "clinical data," meaning "accompanying clinical information" and "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity."
  • The document does not specify the number of experts, nor their qualifications (e.g., allergists, physicians with specific experience) who established this clinical ground truth.

4. Adjudication Method for the Test Set

• Precision, Linearity, Specificity: Not applicable, as these are quantitative analytical measurements.
• Clinical Studies: The document does not describe an adjudication method for the "clinical data" to establish ground truth. It simply refers to "accompanying clinical information" or "clinical documentation."

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

• No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic assay, not an imaging or interpretation aid for human readers. It provides a quantitative measurement.

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

• Yes, the conducted studies are standalone evaluations of the assay's performance. The IMMULITE® 2000 3gAllergy™ Specific IgE Assay itself is the "algorithm/device" in this context, providing a quantitative value. The clinical study compares its output against clinical information, not against human reader interpretations of results.

7. The Type of Ground Truth Used

• Precision, Linearity, Specificity: Ground truth is established by laboratory standards, known concentrations, and controlled experimental conditions for biochemical reactions.
• Clinical Studies: The ground truth used was "clinical data," which includes "case histories of suspected clinical reactions" and "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This falls under outcomes data / clinical diagnosis as determined by medical professionals.

8. The Sample Size for the Training Set

• The document does not describe a separate "training set" for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay. This device is an in vitro diagnostic assay, typically developed and validated using a different paradigm than AI/machine learning algorithms that require distinct training, validation, and test sets. The studies described are performance evaluations of the assay itself.

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

• As there is no mention of a "training set" in the context of this immunoassay's development as an AI/ML device, this question is not applicable. The development of such assays involves optimizing reagents and conditions rather than training an algorithm on a data set with established ground truths.

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