(72 days)
The LIAISON® EA 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) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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 infectious mononucleosis.
The DiaSorin LIAISON® EA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EA 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® EA IgG is an indirect chemiluminescence immunassay (CLIA) technology on the LIAISON Analyzer family* for the qualitative determination of IgG antibodies to Epstine-Barr virus (EBV) early antigen-diffuse [ea(D)] in human serum.
The LIAISON® EA IgG Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EA IgG assay on the LIAISON® Analyzer family.
The provided document is a 510(k) summary for a medical device called LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on modifications made to the control set. The information necessary to fully address all parts of your request, particularly those related to detailed study methodologies, expert qualifications, and specific numerical acceptance criteria/results for diagnostic accuracy (like sensitivity/specificity or AUROC), is not present in this 510(k) summary. This document primarily focuses on demonstrating substantial equivalence through performance characteristics of the controls and proving that changes do not introduce new risks to the assay's performance, rather than a full diagnostic accuracy study of the assay itself.
However, I can extract and infer the following:
1. A table of acceptance criteria and the reported device performance
The document states that "Non-clinical verification and validation testing conducted with the LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria". While the specific numerical acceptance criteria are not explicitly detailed (e.g., a specific percentage for precision or commutability), the types of performance evaluated and confirmed are listed.
| Performance Characteristic Tested (Acceptance Criteria Mentioned but not quantified) | Reported Device Performance |
|---|---|
| Commutability between samples and controls (matrix effect) | Modified device meets "predetermined acceptance criteria" for commutability between samples and controls. |
| Precision equivalence between samples and controls (20 Day Precision) | Modified device meets "predetermined acceptance criteria" for precision equivalence between samples and controls. |
| Control value assignment | Modified device meets "predetermined acceptance criteria" for control value assignment. |
| Control range definition | Modified device meets "predetermined acceptance criteria" for control range definition. |
| Shelf-life stability (12 months at 2-8°C) | Real Time Stability testing supports a shelf-life of 12 months at 2-8°C. |
| Open Use Stability (8 weeks at 2-8°C between uses) | Real Time Stability testing supports 8 weeks open use stability when stored at 2-8°C between uses. (This is an improvement from the predicate's 4 weeks). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the specific sample sizes used for the "test set" in terms of number of patient samples. The studies mentioned ("Commutability," "Precision equivalence," "Control value assignment," "Control range definition," and "Real Time Stability") relate to the performance of the controls and the assay system with these controls. Information regarding data provenance (country, retrospective/prospective) for these specific validation studies is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the context of this 510(k) summary. The document pertains to a serological assay (LIAISON® EA IgG) and its controls, not an AI or imaging device that uses expert-established ground truth for a test set in the traditional sense of diagnostic accuracy studies. The "ground truth" for a serological assay would typically be established through other laboratory methods, clinical diagnosis, or a composite reference standard, rather than expert interpretation of images or other data that requires such qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. See point 3.
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
This is not an AI-assisted device and therefore no MRMC study or AI-related effectiveness study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. It is a serological immunoassay kit and its controls.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the LIAISON® EA IgG assay itself (not the controls), the "ground truth" for its intended use is defined by its ability to detect specific IgG antibodies to EBV early antigen-diffuse [EA(D)]. This is a biochemical "truth" established by the immunological reaction in the assay. The assay is intended to be used "in conjunction with other EBV markers" as an aid in clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infectious mononucleosis. Therefore, the ultimate clinical ground truth for the disease diagnosis would involve a combination of various EBV markers and clinical symptoms/outcomes, but the "ground truth" for the device's performance itself is its accuracy in detecting the target antibody. The document does not provide details on how the original assay (K060204) was validated against clinical ground truth or other reference methods in terms of sensitivity and specificity for disease diagnosis. This 510(k) is specifically for modifications to the controls and showing they do not negatively impact the previously cleared assay.
8. The sample size for the training set
This is not an AI algorithm. The concept of a "training set" in the machine learning sense does not apply here. The "training" for such an assay involves method development and optimization using various reagent lots, antigen sources, and panels of known positive/negative samples, but these are not quantified in terms of a "training set" like in AI.
9. How the ground truth for the training set was established
Not applicable as described for AI (see point 8). For the development of the assay, the "ground truth" for calibrators and controls would be established through careful characterization using reference methods, purified antigens/antibodies, and panels of clinically characterized patient samples (e.g., samples from confirmed EBV infections and healthy individuals), but specific details are not provided in this summary.
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).