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For in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay on the ADVIA Centaur system.

The ADVIA Centaur® Calibrator 80 is a 2 level human IgE in equine serum containing detergents and preservatives. All human source materials used in the manufacture of this product was tested by FDA-approved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2. The Total IgE Calibrators have expected values of 35 and 1825 IU/mL. The Calibrator 80 (2.0 mL/vial) is lyophilized. Storage for the lyophilized calibrators is at 2 - 8℃ until expiration date specified on label, the reconstituted calibrator storage is at 2 - 8ºC up to 60 days, and on board is up to 8 hours.

The provided text describes the ADVIA Centaur® Calibrator 80, a device for in vitro diagnostic use in calibrating the ADVIA Centaur® Total IgE (tIgE) quantitative assay. As a calibrator, its performance is assessed through its traceability, value assignment, and stability, rather than metrics like sensitivity or specificity typically associated with diagnostic tests for disease detection.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device's performance was "validated following procedures of Siemens Healthcare Diagnostics." Specific numerical acceptance criteria are not explicitly detailed in this summary. However, the performance characteristics are implicitly linked to its ability to function as a calibrator with specified concentrations and stability.

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

The document does not specify a separate "test set" in the context of device performance studies in the way a diagnostic algorithm might have. Instead, it refers to the validation of traceability, value assignment, and stability. There is no information provided regarding sample size or data provenance (country of origin, retrospective/prospective) for these validation studies.

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

This information is not applicable or provided for a calibrator device. Calibrators are assigned values based on metrological traceability to reference standards, not through expert-established ground truth in the context of clinical interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for a calibrator device. Adjudication methods are relevant for studies involving human interpretation or uncertain outcomes, which is not the case for a calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for a calibrator device. These studies are typically employed to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance in interpreting images or data. The ADVIA Centaur® Calibrator 80 is a physical substance used to standardize an assay, not an interpretative tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

This device is not an algorithm, so a "standalone algorithm performance study" is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for a calibrator is established through metrological traceability to reference standards. The document mentions "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 80 have been validated following procedures of Siemens Healthcare Diagnostics." This implies that the assigned values (35 IU/mL and 1825 IU/mL) are linked back to a defined hierarchy of standards, ensuring accuracy and consistency. Human IgE is used as the active ingredient.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a calibrator, not a machine learning algorithm that requires a "training set."

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

This information is not applicable or provided as there is no "training set" for this type of device.

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