HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM

K983656 · Zeus Scientific, Inc. · LGC · Mar 18, 1999 · Microbiology

Device Facts

• Record ID: K983656
• Device Name: HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LGC · Microbiology
• Decision Date: Mar 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. Herpes Simples Virus (HSV) -1 and/or HSV-2 IgM ELISA Test System is intended for the qualitative detection of IgM antibodies to Herpes Simplex Virus type 1 and 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 or HSV-2, but can not disginguish between the two IgM antibodies. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.

Device Story

The HSV-1 and/or HSV-2 IgM ELISA Test System is an in vitro diagnostic assay used in clinical laboratory settings. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgM antibodies in human serum samples. The device provides qualitative results to assist healthcare providers in identifying primary or reactivated HSV-1/2 infections. It does not differentiate between the two virus types. Results are interpreted by laboratory professionals to support clinical diagnosis and patient management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

ELISA-based immunoassay for qualitative detection of IgM antibodies. In vitro diagnostic test system. Requires laboratory equipment for processing and analysis.

Indications for Use

Indicated for qualitative detection of IgM antibodies to HSV-1 and/or HSV-2 in human serum to evaluate serologic evidence of primary or reactivated infection. Does not distinguish between HSV-1 and HSV-2 IgM antibodies.

Regulatory Classification

Identification

Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).

Submission Summary (Full Text)

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MAR 1 8 1000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K983656

> Trade Name: HSV-1 and/or HSV-2 IgM ELISA Test System Regulatory Class: III Product Code: LGC Dated: February 3, 1999 Received: February 5, 1999

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 Autman

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): _____ K983656

HSV-1 and/or HSV-2 IgM ELISA Test System Device Name:

Indications for Use:

The Zeus Scientific, Inc. Herpes Simples Virus (HSV) -1 and/or HSV-2 IgM ELISA Test System is intended for the qualitative detection of IgM antibodies to Herpes Simplex Virus type 1 and 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 or HSV-2, but can not disginguish between the two IgM antibodies. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

nical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801,109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)