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The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum.

The LIAISON® VCA IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® VCA IgG assay on the LIAISON® Analyzer family.

The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum.

The LIAISON® EBNA IgG Serum Control Set (negative) consists of liquid ready-touse controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® EBNA IgG assay on the LIAISON® Analyzer family.

This document describes two devices, the LIAISON® VCA IgG and LIAISON® EBNA IgG assays and their respective Serum Control Sets. The provided text primarily focuses on the control sets, detailing the modifications made to them and the studies conducted to demonstrate that these modifications do not compromise the performance or safety of the assays.

A. Acceptance Criteria and Reported Device Performance (LIAISON® VCA IgG Serum Control Set & LIAISON® EBNA IgG Serum Control Set)

The acceptance criteria stated for both control sets are related to their ability to function as intended without introducing new risks after modifications. The performance data section describes the types of studies conducted rather than specific numeric acceptance criteria and resulting reported performance values.

However, based on the description of the studies, we can infer the acceptance criteria and a summary of reported performance:

1. Commutability between samples and controls (matrix effect).
2. Precision equivalence between samples and controls.
3. Accurate control value assignment.
4. Appropriate control range definition. | "Non-clinical verification and validation testing... demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."
   Specific values are not provided. |
   | Stability (Shelf-life) | The control set should maintain its performance over a 12-month shelf-life when stored at 2-8°C. | Supported a "Shelf-life of 12 months at (2-8°C)". |
   | Stability (Open Use) | The control set should maintain its performance for eight (8) weeks after opening when stored at 2-8°C between uses. | Supported "Eight (8) weeks open use stability when stored at 2-8°C between uses." |
   | Risk Assessment | The modifications should not introduce any new risks to the performance of the device. | "Based on the results from the validation and verification activities, the modifications to the LIAISON® VCA IgG Serum Control Set [and EBNA IgG Serum Control Set] do not introduce any new risks to the performance of the device." |

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

The document does not specify the exact sample sizes for the test sets used in the validation and verification studies (e.g., for commutability, precision, value assignment, or stability). It only states that these studies were conducted.

The data provenance is not explicitly mentioned with respect to country of origin, but the controls are described as being made from "Human serum/defibrinated plasma." The studies are retrospective as they validated modifications to an already cleared device.

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

This information is not provided. The document describes in-vitro diagnostic devices (immunoassays and control sets), and the ground truth for such devices is typically established through reference methods, certified materials, or clinical samples with confirmed status, rather than expert consensus on interpretation of device output.

D. Adjudication Method

Not applicable for this type of in-vitro diagnostic device validation. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by human readers.

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

Not applicable. This is an in-vitro diagnostic device, not an imaging or interpretation assistance device for human readers. The studies focus on the analytical performance of the control sets themselves.

F. Standalone Performance

The devices in question are control sets for existing immunoassays. Their performance is inherently tied to the assay they are controlling. The document describes "non-clinical verification and validation testing" demonstrating that the modified control sets meet acceptance criteria, implying an assessment of their analytical performance in a standalone context as control materials. However, "standalone" in the context of an algorithm without human-in-the-loop performance is not relevant here. The "performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL," indicating their intended specific use.

G. Type of Ground Truth Used

The ground truth for the performance of these control sets would be established against the expected performance of the LIAISON® VCA IgG and LIAISON® EBNA IgG assays. This would involve using:

• Reference materials: Potentially, certified reference materials or established in-house reference materials to assign values and check accuracy.
• Clinical samples: Patient samples with known positive or negative status (likely determined by established reference methods for EBV) would be used to assess commutability and ensure the controls behave similarly to actual patient samples.
• Established assay performance: The predicate device's known performance characteristics (precision, accuracy, etc.) would serve as a benchmark for evaluating the equivalency of the modified control sets.

The document implicitly refers to this by stating the studies "demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."

H. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this is an in-vitro diagnostic device (immunoassay control set). The studies described are validation and verification studies for analytical performance and stability, not a machine learning model.

I. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a machine learning training set.

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