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510(k) Data Aggregation
(101 days)
The Epstein Barr Virus Viral Capsid Antigen (EBV-VCA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV-VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV-VCA IgG ELISA should be used in conjunction with other EBV serologies.
The EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-VCA antigen in human serum.
Acceptance Criteria and Device Performance for PANBIO EBV-VCA IgG ELISA Kit
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria values for the performance metrics (sensitivity, specificity, and agreement). However, it reports the calculated performance against the defined EBV status. For the purpose of this response, the reported performance values will be considered as effectively meeting the implicit criteria for substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Study Site 2, USA) | Reported Device Performance (Study Site 3, Australia) |
|---|---|---|---|
| Serological Sensitivity (Acute) | Sufficient to demonstrate equivalence | 69.2% (95% CI: 48.2 – 85.7%) | 92.9% (95% CI: 80.5 – 98.5%) |
| Serological Sensitivity (Past) | Sufficient to demonstrate equivalence | 94.1% (95% CI: 87.6 – 97.8%) | 89.3% (95% CI: 85.6 – 93.1%) |
| Serological Specificity (Negative) | Sufficient to demonstrate equivalence | 96.4% (95% CI: 81.6 – 99.9%) | 91.7% (95% CI: 80.0 – 97.7%) |
| Serological Agreement | Sufficient to demonstrate equivalence | 90.4% (95% CI: 84.6 – 94.5%) | 90.1% (95% CI: 86.4 – 93.0%) |
| Cross-Reactivity (Specificity) | 0% positive results for disease panel | 0/29 (100% true negative) | N/A (Not reported separately for this site) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Study Site 2 (USA):
- Sample Size: 156 frozen retrospective sera.
- Data Provenance: Maryland, USA. The samples were retrospective, meaning they were collected in the past for other purposes (EBV testing) and then re-analyzed.
- Study Site 3 (Australia):
- Sample Size: 352 prospective sera.
- Data Provenance: Queensland, Australia. The samples were prospective, meaning they were collected specifically for this study.
- Cross-Reactivity Study (Study Site 5):
- Sample Size: 29 specimens.
- Data Provenance: Not explicitly stated for specific geography, but the study was conducted to establish analytical specificity for the EBV-VCA IgG ELISA Test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish the "EBV status" of the sera in either Study Site 2 or Study Site 3. The ground truth (EBV Status) was determined using "EBV ELISA assays from an alternate manufacturer" and other EBV serologies (VCA IgM, EBNA IgG) to categorize samples as "Seronegative," "Acute Infectious Mononucleosis," or "Past Infection." This implies reliance on established laboratory diagnostic methods rather than individual expert adjudication of raw data.
4. Adjudication Method for the Test Set:
Not applicable in the traditional sense of human expert adjudication. The "EBV Status" (ground truth) was established through the results of other EBV ELISA assays and serological markers, not by human experts adjudicating the PANBIO device's results. The comparison was to an established diagnostic status determined by alternative, presumably validated, methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
This information is not applicable. The device described is an in vitro diagnostic ELISA kit for detecting antibodies in serum, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation or MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, the studies presented (Study Site 2 and Study Site 3) evaluate the standalone performance of the PANBIO EBV-VCA IgG ELISA kit. The results (sensitivity, specificity, agreement) are calculated solely based on the device's output compared to the established EBV status of the samples. There is no mention of human interpretation or involvement in the final classification of the device's results.
7. The Type of Ground Truth Used:
The ground truth used was expert consensus on serological markers/established diagnostic assays. For the sensitivity and specificity studies (Study Site 2 & 3), the "EBV Status" was determined by a combination of other EBV serological assays (VCA IgG, VCA IgM, EBNA IgG) from an alternate manufacturer. For the cross-reactivity study, the ground truth was "confirmed disease other than Epstein Barr Virus" as characterized prior to analysis.
8. The Sample Size for the Training Set:
The document does not explicitly state a separate "training set" size. For an ELISA kit, development often involves optimization and calibration using various samples, but these are typically not referred to as a "training set" in the same way as machine learning models. The provided studies focus on validation/test sets.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicitly defined "training set" for the purpose of a machine learning model, the method for establishing its ground truth is not provided. The development and calibration of an ELISA kit involve establishing cutoff values and validating reagent performance, which would inherently rely on characterized samples but not a "training set" in the AI sense.
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