ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA

K981120 · Zeus Scientific, Inc. · LSE · Aug 21, 1998 · Microbiology

Device Facts

• Record ID: K981120
• Device Name: ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
• Applicant: Zeus Scientific, Inc.
• Product Code: LSE · Microbiology
• Decision Date: Aug 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.

Device Story

The Zeus Scientific, Inc. anti-EBV EA IgG ELISA Test System is an in vitro diagnostic assay used to detect IgG antibodies against EBV Early Antigen (EA) in human serum. The device utilizes Enzyme-Linked Immunosorbent Assay (ELISA) technology. It is intended for use in clinical laboratory settings by trained personnel. The test results provide qualitative or semi-quantitative data regarding the presence of anti-EBV EA IgG antibodies, which clinicians use in conjunction with other clinical findings and antibody titers (e.g., EBNA, VCA) to assess stages of EBV infection or potential reactivation of latent viral states. The device aids in the diagnosis of infectious mononucleosis.

Technological Characteristics

ELISA-based immunoassay for the detection of IgG antibodies to EBV EA in human serum. The system relies on standard immunological binding principles. No specific materials, energy sources, or software algorithms are detailed in the provided documentation.

Indications for Use

Indicated for the detection of IgG antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human serum specimens as an aid in the diagnosis of infectious mononucleosis. Not established for the diagnosis of acute infectious mononucleosis.

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).

Submission Summary (Full Text)

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Public Health Service

AUG 21 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark J. Kopnitsky Vice President, Research · and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876

Re: K981120

Trade Name: Zeus Scientific, Inc., anti-EBV EA IgG ELISA Test System Regulatory Class: I Product Code: LSE Dated: June 9, 1998 Received: June 10, 1998

Dear Mr. Kopnitsky:

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 Regulations, 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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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510(k) Number (if known). K981120

Zeus Scientific, Inc., anti-EBV EA IgG ELISA Test System Device Name:

Indications for Use:

Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting Iymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. In underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic.

Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes which lasts probably for life. Reactivation of the latent viral carrier state, as evidenced by increased rates of virus shedding, is enhanced by immunosuppression, pregnancy, malnutrition or disease.

Antibody titers to specific EBV antigens correlate with different stages of infectious mononucleosis. Antibodies to EA may appear transiently for up to three months or longer during the acute phase of IM in 85% of patients. Antibodies to EA together with antibodies to EBNA and high titers of IgG to VCA may be associated with reactivation of the latent viral carrier state.

This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubace

inical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801, 109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)