(299 days)
ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children.
Microtiter ELISA kit detecting EBNA antibodies
The provided text describes a 510(k) premarket notification for the "ImmunoWELL EBNA IgG Test" and its substantial equivalence to a predicate device. This document focuses on the performance of an in vitro diagnostic (IVD) device and not an AI/ML powered medical device. Therefore, several requested categories are not applicable.
Here's an analysis of the acceptance criteria and study data presented:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or agreement percentages. Instead, the criterion for acceptance seems to be demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is presented as a comparison table between the new device and the predicate.
| Criterion Category | Acceptance Criteria (Implicit) | ImmunoWELL EBNA IgG Test Performance |
|---|---|---|
| Agreement | Demonstrate "essentially identical" performance or "substantially the same" serological information compared to the predicate. | See Table 1: Gull EIA vs. ImmunoWELL |
Table 1: Gull EIA vs. ImmunoWELL EBNA IgG Test Performance (Clinical Samples)
| Predicate Device (Gull EIA) | ||||
|---|---|---|---|---|
| Past/Recent | Current | No Past Infection | ||
| New Device (ImmunoWELL) | Past/Recent | 65 | 8 | 0 |
| Current | 0 | 7 | 0 | |
| No Past Infection | 5 | 1 | 8 | |
| Total Samples | 70 | 16 | 8 |
Interpretation of Table 1:
The table compares the classification of patient samples by the new ImmunoWELL EBNA IgG Test against the predicate Gull EIA. The diagonal elements (65, 7, 8) represent agreement between the two devices. Off-diagonal elements represent disagreement. For example:
- 65 samples were classified as "Past/Recent" by both devices.
- 8 samples were classified as "Past/Recent" by ImmunoWELL but "Current" by Gull EIA.
- 5 samples were classified as "No Past Infection" by ImmunoWELL but "Past/Recent" by Gull EIA.
The summary states the predicate and new device "perform essentially the same when testing sers from suspected patients."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The total number of samples used in the comparison study (Table 1) is 70 + 16 + 8 = 94 samples.
- Data Provenance: The document does not explicitly state the country of origin. It describes the samples as "sérums from suspected patients," implying prospective or retrospective clinical samples from a patient population relevant to the intended use. It does not explicitly state whether it’s retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For an IVD device, the "ground truth" is typically established by either a reference method, confirmed clinical diagnosis, or a composite reference standard, rather than expert interpretation of images or other subjective data. In this case, the predicate device (Gull EIA) serves as the comparator for performance, effectively acting as an established "truth" for comparison within the context of substantial equivalence.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used when human interpretation is the primary method of establishing ground truth or performance. For this IVD comparison, the results are quantitative or qualitative classifications from two different assays, making an adjudication method unnecessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- Not Applicable. This is an IVD device study, not an AI-powered image analysis or diagnostic support system that typically involves multiple human readers evaluating cases with and without AI assistance. Therefore, an MRMC study and effect size in terms context of AI assistance are not relevant here.
6. If a Standalone Performance (Algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The entire study described by Table 1 is a standalone performance comparison. The ImmunoWELL EBNA IgG Test, like the predicate, is an assay that produces an output (qualitative detection of IgG antibody) without immediate human-in-the-loop intervention during the assay execution and primary result generation. The interpretation of the results "in conjunction with other testing" is part of clinical utility, but the device performance itself is standalone.
7. The Type of Ground Truth Used
- The "ground truth" in this context is implicitly the results obtained from the legally marketed predicate device (Gull Laboratories' Epstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit). The study's goal is to demonstrate that the new device's results are "essentially the same" as those from the predicate.
8. The Sample Size for the Training Set
- Not applicable. The "ImmunoWELL EBNA IgG Test" is an ELISA kit, which is a biochemical assay, not an AI/ML algorithm that requires a training set in the conventional sense. The development of such a kit involves reagent optimization and validation, but not machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for training in the sense of machine learning.
§ 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).