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ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems:

The ADVIA Centaur® HAV (gM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.

ADVIA Centaur CP system:

The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.

The ADVIA Centaur HAV IgM reagent kit contains the following:

• ReadyPack® primary reagent pack containing ADVIA Centaur HAV IgM Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent
• ReadyPack ancillary pack containing ADVIA Centaur HAV IgM Ancillary Reagent
• ADVIA Centaur HAV IgM Low Calibrator
• ADVIA Centaur HAV IgM High Calibrator
• ADVIA Centaur systems HAV IgM Master Curve cards
• ADVIA Centaur systems HAV IgM Calibrator Assigned Value Card

The HAV IgM ReadyPack consists of the following:

Primary reagent pack

• The Lite Reagent is an anti-HAV mouse monoclonal antibody (F(ab) ¿ fragment: ~0.3 µg/mL) labeled with acridinium ester in buffer with bovine serum albumin, surfactant, sodium azide (

The provided text describes the acceptance criteria and a study demonstrating the performance of the ADVIA® Centaur HAV IgM (aHAVM) assay when including pediatric populations (2-21 years).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the pediatric population study in a table format. However, it presents the results of a comparative study with a "Comparative anti-HAV IgM Assay" and calculates agreement percentages. We can infer that the implicit acceptance criteria would be for these agreement percentages to be acceptably high.

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

• Sample Size for Test Set: 132 pediatric serum samples.
• Data Provenance: The origin of the data (e.g., country) is not specified. It is a retrospective study ("One hundred and thirty-two (132) pediatric serum samples (male and female, age range from 2 to 21 years) from suspected positive or high risk population were evaluated...").

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

The document does not mention the use of experts to establish a "ground truth" for the test set. Instead, it uses a "commercially available assay" as a comparator to assess agreement. This suggests the "ground truth" for the comparison was established by the results of this comparator assay, rather than a panel of human experts.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of expert adjudication for the test set, as the comparison was made against another commercial assay.

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

Not applicable. This is an in vitro diagnostic immunoassay, not an imaging device or AI-assisted diagnostic tool typically evaluated with MRMC studies involving human readers.

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

Yes, the study described is a standalone performance evaluation of the ADVIA Centaur HAV IgM assay. It compares the device's results directly against another commercial assay without human intervention in the interpretation or decision-making process for the device itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the results of a "commercially available assay" which served as the comparative method. The samples were collected from a "suspected positive or high-risk population," implying clinical presentation also factored into their selection, but the definitive comparison was against the other assay.

8. The Sample Size for the Training Set

The document does not mention a distinct "training set" as it refers to a comparative study for adding pediatric populations. The assay itself was previously cleared or approved (K081716, P040018), and this submission is for an expanded indication. It's likely that a training set would have been used for the initial development and validation of the original assay, but that information is not provided here. The focus of this submission's study is limited to the pediatric population expansion.

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

Not applicable, as no training set is explicitly discussed in this document for the purpose of the reported study. For the original assay development, the ground truth would have been established through clinical diagnosis, potentially using PCR, viral culture, or other definitive methods, but this is outside the scope of the provided text.

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