ZEUS ELISA HSV GG-2 IGG TEST SYSTEM

K103603 · Zeus Scientific, Inc. · MYF · May 20, 2011 · Microbiology

Device Facts

• Record ID: K103603
• Device Name: ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MYF · Microbiology
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Device Story

ZEUS ELISA HSV gG-2 IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgG antibodies to HSV-2 glycoprotein G (gG-2) in human serum. Device uses polystyrene 96-well plates sensitized with affinity-purified HSV-2 native antigen. Patient serum is incubated in wells; antigen-specific IgG binds to immobilized antigen. After washing, horseradish peroxidase-conjugated goat anti-human IgG (Fc-specific) is added. Following further incubation and washing, peroxidase substrate (TMB) is added, causing color change proportional to bound antibody. Reaction is stopped and optical density measured via spectrophotometer. Results are interpreted against a cutoff value (Index Value <= 0.90 negative; 0.91-1.09 equivocal; >= 1.10 positive). Used in clinical laboratories by trained personnel to aid in HSV-2 diagnosis. Output assists clinicians in evaluating patient infection status based on clinical history and epidemiological data.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence is based on analytical performance characteristics and comparison to the predicate device.

Technological Characteristics

Immunoassay (ELISA) using affinity-purified HSV-2 native antigen on polystyrene 96-well plates. Detection via horseradish peroxidase-conjugated goat anti-human IgG (Fc-specific) and TMB substrate. Requires spectrophotometer for optical density measurement. Qualitative interpretation based on index values. No automated software algorithm; manual or instrument-assisted photometric reading.

Indications for Use

Indicated for sexually active individuals or pregnant women to aid in the presumptive diagnosis of HSV-2 infection. Not for pediatric, neonatal, or immunocompromised populations.

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).

Predicate Devices

• HerpeSelect 1 and 2 Immunoblot IgG (K000238)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Zeus Scientific, Inc. c/o Ewa K. Nadolczak Manager, Clinical Affairs 200 Evans Way Branchburg, NJ 08876

MAY 2 0 2011

Re: k103603

Trade/Device Name: Zeus ELISA HSV gG-2 IgG Test System Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: April 13, 2011 Received: April 14, 2011

Dear Ms. Nadolczak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 – Ewa K. Nadolczak

will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Uwe Schuf Ar.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K103603

Device Name: ZEUS ELISA HSV gG-2 IgG Test System Indications for Use:

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.

The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.

The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Uve Sch

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k103603