ImmunoWELL. VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Device Description

Microtiter ELISA kit detecting VCA IgG antibodies

AI/ML Overview

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes a comparative study with a predicate device and concludes that the new device performs "essentially the same."

However, we can infer the implicit acceptance criteria based on the study's design: demonstrating substantial equivalence to the predicate device. The performance data presented is a cross-tabulation comparing the new device (ImmunoWELL) with an "Alternate EIA" (which, based on the context of the predicate device, likely refers to the Gull EIA, or a similar method used for comparison).

Performance Criteria (Implicit)	Reported Device Performance (ImmunoWELL VCA IgG Test vs. Alternate EIA/Predicate)
Agreement in "Past/Recent" infection status	65 cases agreed (ImmunoWELL: Past/Recent, Alternate: Past/Recent)
Agreement in "Current" infection status	7 cases agreed (ImmunoWELL: Current, Alternate: Current)
Agreement in "No Past Infection" status	8 cases agreed (ImmunoWELL: No Past Infection, Alternate: No Past Infection)
Discrepancies (ImmunoWELL Past/Recent, Alternate Current)	8 cases
Discrepancies (ImmunoWELL No Past Infection, Alternate Past/Recent)	5 cases
Discrepancies (ImmunoWELL No Past Infection, Alternate Current)	1 case
Overall Conclusion	"The predicate device and the new device perform essentially the same when testing sera from suspected patients."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The sum of all cases in the provided table is 65 + 8 + 0 + 0 + 7 + 0 + 5 + 1 + 8 = 94 samples.
Data Provenance: Not explicitly stated. The document does not mention the country of origin or whether the data was retrospective or prospective. It only refers to "sera from suspected patients."

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided in the text. The study relies on a comparison against an "Alternate EIA" (likely the predicate device or a similar established method) rather than a defined ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given that the comparison is between two EIA tests, there's no indication of an adjudication process in the traditional sense involving human review of discrepancies beyond the test results themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This study describes the performance of an in vitro diagnostic (IVD) device, which is an automated test, not a system designed to assist human readers in image interpretation or similar tasks where MRMC studies are typically performed.

6. Standalone (Algorithm Only) Performance

Yes, the study describes the standalone performance of the ImmunoWELL VCA IgG Test. Since it is an ELISA kit, its performance is inherently "algorithm only" in the context of an IVD, meaning it operates independently to produce a result. The study compares this standalone performance to another standalone IVD (the predicate device).

7. Type of Ground Truth Used

The study uses the results of an "Alternate EIA" (likely the predicate device or a highly similar established method) as the reference for comparison. While not explicitly termed "ground truth," this serves as the benchmark against which the new device's performance is measured to establish substantial equivalence. It's a comparative agreement study rather than a direct validation against a clinical "ground truth" like pathology or long-term outcomes. The text mentions the results "can serve as an aid in the diagnosis of infectious mononucleosis (IM)" when used with other tests, indicating that a definitive diagnosis relies on a panel of results, not just this one.

8. Sample Size for the Training Set

This information is not provided in the text. For IVD devices like this ELISA kit, there isn't typically a "training set" in the machine learning sense. The device's parameters and performance characteristics are established through analytical and clinical validation studies, rather than by training a learnable algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an ELISA kit, this question is not applicable. The development of such a kit involves biochemical and immunological design, optimization, and characterization rather than a data-driven training process for an algorithm.

Summary

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510(k) Summary AUG | U

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	ImmunoWELL VCA IgG Test
Common, usual, or classification name	Epstein-Barr Virus Viral Capsid Antigen IgG Test
Classification Number (if known)	866.3235

Identification of the legally marketed device substantial equivalence is claimed:

Epstein-Barr Viral Capsid Antigen IgG ELISA Kit, Gull Laboratories, Inc.

Description of the new device:

Microtiter ELISA kit detecting VCA IgG antibodies

Intended Use of New Device:

ImmunoWELL VCA IgG Test is for the qualitative detection of IgG antibudy to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG rest is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

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

The new device and the predicate ElA device are essentially identical. Both use VCA antigens and measure antibodies 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.

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

ImmunoWELL VCA IgG Test

Page I

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Table 1: Gull ElA

Alternate EIA

		Past/Recent	Current	No Past Infection
ImmunoWELL	Past/Recent	65	8	0
ImmunoWELL	Current	0	7	0
ImmunoWELL	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 ImmunoWELL EBV assays (EBNA 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.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the eagle's head and body.

AUG 10 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K973940/S2 ImmunoWELL® EBV VCA IgG Test Trade Name: Requlatory Class: T Product Code: LSE 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 regulation (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 Register. 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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Page 2

This letter will allow you to beqin 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 requlation entitled, "Misbranding 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K973940

Device Name: ImmunoWELL VCA IgG Test

Indications for Use: ImmunoWELL. VCA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgG test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgM, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

(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)

Woody Dubois

(Division sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973940

Prescription Use X (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).