(144 days)
For in vitro diagnostic use only.
For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay.
May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.
The SeraQuest EB NA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against Epstein-Barr virus nuclear antigen, in human serum.
The Calibrators in the SeraQuest EB NA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Here's an analysis of the provided text regarding the SeraQuest® EB NA IgG device, focusing on acceptance criteria, study details, and ground truth establishment:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SeraQuest EB NA IgG test were established relative to the predicate device, Gull Laboratories' EBNA IgG ELISA test. The performance metrics are reported as relative sensitivity, relative specificity, and overall agreement.
| Metric | Acceptance Criteria (Implied / Comparator Performance) | Reported Device Performance (SeraQuest EB NA IgG) |
|---|---|---|
| Relative Sensitivity | Performance comparable to predicate device | 99.0 % (95% C.I.: 97.2 % to 100 %) |
| Relative Specificity | Performance comparable to predicate device | 95.6 % (95% C.I.: 89.8 % to 100 %) |
| Overall Agreement | Performance comparable to predicate device | 98.0 % (95% C.I.: 95.8 % to 100 %) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 157 archival serum specimens.
- Data Provenance: The specimens included:
- 80 from patients whose sera were submitted to a clinical laboratory for EBV serological testing.
- 11 from donors reported to be positive for EBV antibodies, obtained through serum brokers.
- 66 from normal serum donors.
- The term "archival serum specimens" suggests a retrospective nature for the study. The country of origin is not explicitly stated, but the applicant (Quest International, Inc.) is based in North Miami, FL, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established by the predicate device, the Gull Laboratories' EBNA IgG test. Therefore, no human experts were explicitly used to establish ground truth in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. The study compared the new device (SeraQuest EB NA IgG) directly against a predicate device (Gull Laboratories' EBNA IgG test). There was no adjudication process involving multiple human readers to resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study compares a new in-vitro diagnostic device to a predicate in-vitro diagnostic device, not human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The SeraQuest EB NA IgG test is an in-vitro diagnostic kit and its performance was evaluated directly without human interpretation as part of the primary outcome measure, other than following manufacturers' instructions.
7. The Type of Ground Truth Used
The ground truth for this comparison study was established by the performance of the predicate device, the Gull Laboratories' EBNA IgG ELISA test.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this submission. The SeraQuest EB NA IgG test is a laboratory kit, not an AI/machine learning algorithm requiring a training dataset. The submission focuses on the analytical and clinical performance of the manufactured kit.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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).