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The IMMULITE® 2000 Allergen-Specific IgE is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer – for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgEmediated allergic disorders.

IMMULITE 2000 Allergen-Specific IgE is for in vitro diagnostic use with the IMMULITE 2000 Automated Immunoassay Analvzer. IMMULITE 2000 Allergen-Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. 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 patient sample and the allergen are simultaneously introduced into the reaction tube, which contains an immobilized anti-ligand, and incubated for approximately 30 minutes at 37℃ with intermittent agitation. During this time, allergen-specific IgE in the sample binds to the ligandlabeled allergen, which, in turn, binds to the anti-ligand on the solid phase. Unbound serum is then removed by a centrifugal wash. An alkaline phosphatase-labeled anti-human IgE antibody is introduced, and the reaction tube is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the reaction tube is incubated for a further 5 minutes. The Substrate 15 then added, and the reactive of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphates to yield an unstable intermediate The continuous the presence of this intermediate results in sustained emission of light, thus improving precision by production of this micinied results in casing. The bound complex – and thus also the photon output, providing a window for mample reading, - is directly related to the amount of endogenous IgE specific for the allergen.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Discussion:

The provided text is a 510(k) Summary of Safety and Effectiveness for the IMMULITE® 2000 Allergen-Specific IgE device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (AlaSTAT® Microplate Allergen-Specific IgE).

Crucially, this document does not contain specific acceptance criteria or details of a study designed to prove the device meets those criteria in the way one would expect for a new performance claim or a detailed comparison. Instead, it focuses on demonstrating "Performance Equivalence - Technology Comparison" to a legally marketed predicate device. This means the primary argument for acceptance is that the new device's technology is similar enough, and likely performs equivalently, to an already approved device, rather than establishing new performance benchmarks.

Therefore, many of the requested fields below will be marked as "Not Applicable (N/A)" or "Not Provided" because the document's purpose is not to detail a de novo performance study against explicit acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present explicit, quantitative acceptance criteria for the IMMULITE® 2000 Allergen-Specific IgE. The core of the submission is a claim of "substantial equivalence" based on technological similarities to a predicate device. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device's technology and intended use are comparable to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not provided. The document highlights a "Technology Comparison" for "Performance Equivalence" rather than detailing a specific test set.
• Data Provenance: Not provided.
• Retrospective or Prospective: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. This type of in vitro diagnostic device (IVD) submission for allergen-specific IgE measurement does not typically involve expert readers for establishing ground truth in the way imaging AI or clinical diagnostic algorithms do. The "ground truth" would generally be established by the reference measurement method (e.g., the predicate device or a gold standard IgE assay).
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This document does not describe a study involving expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not applicable to the type of device described (an in vitro diagnostic immunoassay). The device is an automated immunoassay system, not an AI-assisted diagnostic tool for human readers.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: The IMMULITE 2000 is an automated immunoassay analyzer. Its performance is inherently "standalone" in the sense that the measurement is performed by the machine and reagents, without direct human intervention in the assay execution or result computation. However, this isn't an "algorithm only" in the modern AI sense. The document implies that the "technology comparison" serves as the basis for its performance claim.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not explicitly stated. For an immunoassay, the "ground truth" for demonstrating equivalence would typically involve comparison against results from the predicate device (AlaSTAT® Microplate Allergen-Specific IgE) or another established and validated method for measuring allergen-specific IgE. The document strongly implies that the predicate device itself serves as the basis for comparison regarding performance equivalence.

8. The sample size for the training set

• Sample Size: Not applicable. The device is a chemical immunoassay system, not a machine learning algorithm that undergoes a "training phase" with a dataset in the AI sense.

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not applicable. As above, this is an immunoassay, not an AI/ML algorithm requiring a training set with established ground truth.

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