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.

Device Description

Microtiter ELISA kit detecting EBNA antibodies

AI/ML Overview

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.

Summary

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AUG 1 0 1998

510(k) Summary

Contact	Bryan Kiehl
Address	GenBio15222-A Avenue of ScienceSan Diego, CA 92128
Telephone	(619) 592-9300 ext 309
FAX	(619) 592-9400
Email	BKiehl@GenBio.com
Date:	10 August, 1998

Device Name	Immuno WELL EBNA IgG Test
Common, usual, or classification name	Epstein-Barr Virus Nuclear Antigen IgG Test
Classification Number (if known)	866.3235

Identification of the legally marketed device substantial equivalence is claimed:

Ebstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit, Gull Laboratories, Inc.

Description of the new device:

Microtiter ELISA kit detecting EBNA antibodies

Intended Use of New Device:

InmunoWELL 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 BBV viral capsid IgG or IgM, ERV 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.

Technological characteristics of the new device compared to the predicate device:

The new device and the predicate ElA device are essentially identical. Both use EBNA-1 recombinant antigen and measure antibiodies in a microtiter assay format using ELISA technology.

Non-clinical performance data, the summary includes a brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence.

ImmunoWELL EBNA IgG Test

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The predicate device and the new device perform essentially the same when testing sers from suspected patients. The observations are:

Table 1: Gull ElA

		Alternate EIA
		Past/Recent	Current	No Past Infection
ImmunoWELL	Past/Recent	65	8	0
	Current	0	7	0
	No Past Infection	5	1	8

Clinical performance data, the summary includes a brief discussion of clinical tests and how their results support a determination of substantial equivalence.

The device used in conjunction with other ImmunoWFIJ. EBV assays (VCA IgG and VCA IgM) provides clinical information that is substantially the same as serological information using the predicate device.

The summary includes the conclusions drawn from the nonclinical and clinical tests.

This assay yields results that are essentially the same the predicate device.

Immuno WELL EBNA IgG Test

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing strokes, symbolizing health and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG | 0 |998

Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128

Re : K973941/S2

Trade Name: ImmunoWELL® EBV EBNA IgG Test Regulatory Class: I Product Code: LLM Dated: May 15, 1998 Received: May 19, 1998

Dear Dr. Kiehl:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FDA Document Number:

Indications for Use

510(k) Number (if known): K973941

Device Name: ImmunoWELL EBNA Test

Indications for Use: 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.

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodley Dubois

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K973941

Prescription Use > (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).