(490 days)
IMMULITE CMV IgG is designed for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to CMV
IMMULITE® CMV IgG is a solid-phase, two-step, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a CMV antigen.
The Diagnostic Products Corporation IMMULITE® CMV IgG is a device for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum, intended for in vitro diagnostic use to determine serological status to CMV.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | IMMULITE vs. CDC | IMMULITE vs. CYTOMEGELISA II IgG | IMMULITE vs. IMx CMV IgG |
|---|---|---|---|
| Agreement | 100.0% | 98.5% | 99.5% |
| Sensitivity | 100.0% | 97.9% | 100.0% |
| Specificity | 100.0% | 100.0% | 98.7% |
Note: The document implicitly defines acceptance criteria through the comparison of the IMMULITE® CMV IgG with established predicate devices and a proficiency panel from the CDC. The reported performance demonstrates high agreement, sensitivity, and specificity across all comparisons.
2. Sample Size Used for the Test Set and Data Provenance:
- IMMULITE vs. CDC: n = 100
- IMMULITE vs. CYTOMEGELISA II IgG: n = 202
- IMMULITE vs. IMx CMV IgG: n = 200
The document does not explicitly state the country of origin for all data or whether the studies were retrospective or prospective. However, the use of a "CMV proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC)" suggests data provenance from the United States for that specific comparison. For the other comparisons with commercial assays, the provenance of the samples is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth for comparative studies was established by either:
- The results of the "CMV proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC)".
- The results from the predicate devices: BioWhittaker CYTOMEGELISA II IgG and Abbott Laboratories' IMx* CMV IgG.
The process of how the CDC panel established its ground truth or how the predicate devices' ground truths were validated is not detailed.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies or establishing ground truth within the context of these comparative studies. The comparisons directly used the results from the CDC panel or the predicate devices as reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable. The device described, IMMULITE® CMV IgG, is an automated immunoassay for antibody detection, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was effectively conducted. The reported "Agreement," "Sensitivity," and "Specificity" for the IMMULITE® CMV IgG assay were determined by comparing its automated results against established reference standards (the CDC panel and predicate devices). This represents the performance of the algorithm/device itself without human intervention in the interpretation of the primary quantitative signal from the immunoassay to generate the qualitative result.
7. The Type of Ground Truth Used:
The ground truth used for these studies was based on:
- Proficiency Panel Data: From the United States Centers for Disease Control and Prevention (CDC), which likely represents a highly validated reference standard for CMV serology.
- Reference Assay Results: The results obtained from the BioWhittaker CYTOMEGELISA II IgG and Abbott Laboratories' IMx* CMV IgG assays, which are commercially marketed and presumably well-validated devices for CMV IgG detection.
These can be categorized as a form of reference standard comparison or external validation using established methods.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document describes the performance of the product in a clinical comparison rather than detailing the development and training of a machine learning algorithm. As an immunoassay, the concept of a "training set" in the context of AI is not directly applicable. The assay's parameters would have been optimized during its development, but this process is not explicitly detailed as "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided because the IMMULITE® CMV IgG is an immunoassay, not an AI/machine learning model, therefore, the concept of a "training set" and its associated ground truth establishment does not apply in the context of this device and document.
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).