IMMUNOWELL EBV VCA IGG TEST

K973940 · Genbio · LSE · Aug 10, 1998 · Microbiology

Device Facts

• Record ID: K973940
• Device Name: IMMUNOWELL EBV VCA IGG TEST
• Applicant: Genbio
• Product Code: LSE · Microbiology
• Decision Date: Aug 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

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).

Device Story

ImmunoWELL VCA IgG Test is an ELISA-based in vitro diagnostic kit for qualitative detection of IgG antibodies to Epstein-Barr Virus (EBV) viral capsid antigen in human serum. The device utilizes microtiter plate technology to measure antibody presence. It is intended for use in clinical laboratory settings by trained personnel. Results are interpreted by healthcare providers in conjunction with other EBV-specific serological markers (EBNA-1, VCA IgM, early antigen) and heterophile tests to assist in the diagnosis of infectious mononucleosis. The device provides serological information to support clinical decision-making regarding patient infection status.

Clinical Evidence

Clinical performance was evaluated by comparing the ImmunoWELL VCA IgG Test against a predicate EIA device using patient serum samples. Results showed high concordance across categories of past/recent infection, current infection, and no past infection. The device provides clinical information substantially equivalent to the predicate.

Technological Characteristics

Microtiter ELISA assay format; utilizes VCA antigens for antibody detection. Standalone in vitro diagnostic kit. No software, electronic, or mechanical components described.

Indications for Use

Indicated for qualitative detection of IgG antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum. Used as an aid in the diagnosis of infectious mononucleosis (IM) in conjunction with other EBV serological tests (EBNA-1, VCA IgM, early antigen, heterophile tests).

Regulatory Classification

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).

Predicate Devices

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

Submission Summary (Full Text)

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#### 510(k) Summary AUG | U

| Contact | Bryan Kiehl |
|-----------|------------------------------------------------------------|
| Address | GenBio<br>15222-A Avenue of Science<br>San Diego, CA 92128 |
| Telephone | [phone] ext 309 |
| FAX | [phone] |
| Email | [e-mail] |
| 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)