IMMUNOWELL VCA IGM TEST

K973939 · Genbio · LJN · Aug 10, 1998 · Microbiology

Device Facts

• Record ID: K973939
• Device Name: IMMUNOWELL VCA IGM TEST
• Applicant: Genbio
• Product Code: LJN · Microbiology
• Decision Date: Aug 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

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

Device Story

ImmunoWELL VCA IgM Test is an ELISA-based in vitro diagnostic kit; detects IgM antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum samples. Principle of operation involves microtiter assay format using affinity-purified VCA antigen. Used in clinical laboratory settings by trained personnel. Results are interpreted by healthcare providers alongside other serological markers (EBNA-1, VCA IgG, early antigen, heterophile tests) to aid in diagnosing infectious mononucleosis. Provides diagnostic support for patient management.

Clinical Evidence

Bench testing only. Comparison of subject device against predicate using patient sera showed high concordance (88 negative/4 positive agreement; 1 discordant result).

Technological Characteristics

Microtiter ELISA assay; uses affinity-purified Epstein-Barr Virus (EBV) viral capsid antigen (VCA). Manual or automated microtiter plate format.

Indications for Use

Indicated for qualitative detection of IgM 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 tests (EBNA-1, VCA IgG, early antigen, heterophile).

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 IgM ELISA Kit, Gull Laboratories, Inc.

Submission Summary (Full Text)

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#### AUG 10 1998 510(k) Summary

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

### Identification of the legally marketed device substantial equivalence is claimed:

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

Description of the new device:

Microtiter ELISA kit detecting VCA IgM antibodies

### Intended Use of New Device:

ImmowELL VCA IgM Test is for the qualitative detection of IgM antibudy to Epstein-Barr Vinis viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and FRV early antigen tests and/or heteryphile 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 £1A device are essentially identical. Both use VCA affinity purified antigen 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:

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| Table 1: Gull EIA | | | |
|-------------------|----------|----------|----------|
| EIA | | | |
| | | Negative | Positive |
| GB | Negative | 88 | 1 |
| | Positive | 0 | 4 |

:

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 IgG) 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

.AUG 10 1998

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

Re : K973939/S2 Trade Name: ImmunoWELL® EBV VCA IgM Test Regulatory Class: I Product Code: LJN 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, Druq, 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 reqistration, listing of devices, qood 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 requlations 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 regulation 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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#### Page 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 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): K973939

Device Name: ImmunoWELL VCA IgM Test

Indications for Use: ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, 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)

Woodey Aubain
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K973939

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

OR