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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 Analyzer. 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 patient sample and the allergen are simultaneously introduced into the reaction tube, which contains an immobilized anti-ligand, and incubated. 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. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the reaction tube is incubated. The chemiluminescent substrate undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in sustained emission of light, thus improving precision by providing a window for multiple reading. The bound complex - and thus also the photon output, as measured by the luminometer - is directly related to the amount of endogenous IgE specific for the allergen.

The provided text is a 510(k) Summary of Safety and Effectiveness for the IMMULITE® 2000 Allergen-Specific IgE device. It compares the new device to a predicate device, AlaSTAT® Microplate Allergen-Specific IgE. However, it does not explicitly state acceptance criteria or present a study proving the device meets specific acceptance criteria in the format requested.

Instead, it asserts performance equivalence by describing analogous technologies and the overall conclusion is that the data presented led the FDA to grant substantial equivalence.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer based on the information available and acknowledge what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, accuracy, or other performance metrics. It also doesn't provide a table of reported device performance against such criteria. The basis for approval is substantial equivalence to a predicate device.

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Studies are mentioned implicitly for the substantial equivalence claim, but no details are provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This is expected given the nature of the device (an in vitro diagnostic for measuring IgE) where the "ground truth" would typically relate to clinical diagnosis or patient outcomes, which are not detailed here in the context of a specific study for performance evaluation.

4. Adjudication Method

The document does not mention any adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported. This type of study is more common for imaging devices where human interpretation is a key component. This device is an automated immunoassay.

6. Standalone Performance Study

The document implies a standalone performance comparison between the IMMULITE® 2000 and the predicate AlaSTAT® Microplate Allergen-Specific IgE, but it does not present the specific results or metrics from such a study. The focus is on the technological description and the assertion of equivalence.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation studies. For an IgE test, ground truth would typically come from clinical diagnosis of allergic disorders, possibly confirmed by other clinical methods or follow-up, but these details are not provided.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is an immunoassay, not a machine learning algorithm that typically requires a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not applicable and not provided.

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