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The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.

This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.

The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.

The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. Antibodies to HAV (mouse monoclonal) are used for coating magnetic particles (solid phase) and are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV, thus forming an HAV-anti-HAV immune complex. During the second incubation, the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV, that allows the conjugate to bind to the solid phase and thus form a "sandwich" of conjugate antibody-antigen-solid phase antibody. If all HAV added is sequestered in an HAVanti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle.

Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.

The provided text describes a 510(k) premarket notification for the DiaSorin LIAISON® XL Analyzer, referencing the LIAISON® Anti-HAV assay. However, the document does not contain specific acceptance criteria, comprehensive study results demonstrating performance against numerical criteria, or detailed information about sample sizes, ground truth establishment, or expert qualifications for a performance study.

The submission focuses primarily on demonstrating substantial equivalence of the LIAISON® XL Analyzer to its predicate device, the LIAISON® Analyzer, by comparing their features. While it mentions the intended use of the LIAISON® Anti-HAV assay, it does not provide the clinical study data requested.

Therefore, I cannot populate the table with acceptance criteria and reported performance, nor can I provide the requested details about the study design, sample sizes, experts, or ground truth, as this information is not present in the provided text.

The closest information available is the comparison table between the LIAISON® Analyzer and the LIAISON® XL Analyzer, outlining similarities and differences in their features and operational aspects, rather than performance metrics against specific acceptance criteria for a diagnostic test.

Summary of what can be gleaned from the text (and what is explicitly missing):

• Acceptance Criteria & Reported Device Performance: Not provided in the text. The document focuses on demonstrating substantial equivalence to a predicate device through feature comparison, not quantitative performance metrics against pre-defined acceptance criteria for the assay.
• Sample Size (Test Set) & Data Provenance: Not provided.
• Number of Experts & Qualifications: Not provided.
• Adjudication Method: Not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not indicated or described. The device is a laboratory analyzer, not a device requiring human reader interpretation in the context of an MRMC study.
• Standalone Performance Study: A standalone performance study for the LIAISON® Anti-HAV assay on the LIAISON® XL Analyzer would typically include data on sensitivity, specificity, accuracy, precision, etc. This information is not present in the provided text, which is a 510(k) summary focused on the analyzer itself and its substantial equivalence to a previous version.
• Type of Ground Truth: Not provided.
• Sample Size (Training Set): Not applicable, as this is an immunoassay analyzer and assay, not an AI algorithm that requires a training set in that context.
• How Ground Truth for Training Set was Established: Not applicable.

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