HSV-1 ANTIGEN CONTROL SLIDES

K964874 · Viral Antigens, Inc. · GQN · Jul 1, 1997 · Microbiology

Device Facts

• Record ID: K964874
• Device Name: HSV-1 ANTIGEN CONTROL SLIDES
• Applicant: Viral Antigens, Inc.
• Product Code: GQN · Microbiology
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Indications for Use

HSV-1 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-1. Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well. The two wells of cells on the HSV-1 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.

Device Story

HSV-1 Antigen Control Slides serve as quality control tools for laboratory staining reagents used in HSV-1 cell culture assays. Each slide features two wells containing fixed cells: one HSV-1 infected and one uninfected. Laboratory personnel stain these slides alongside patient-inoculated cell cultures. The infected well acts as a positive control, while the uninfected well acts as a negative control. If the positive well fails to stain, it indicates reagent deterioration or procedural failure, prompting the laboratory to discard the test. This process ensures the reliability of staining reagents, preventing the use of faulty materials in clinical diagnostic procedures.

Clinical Evidence

No clinical data provided; device is a quality control material for laboratory staining reagents.

Technological Characteristics

Slides contain fixed cells (one HSV-1 infected, one uninfected) in two wells. Device functions as a biological control for staining reagents. No electronic, software, or mechanical components.

Indications for Use

Indicated for use by clinical laboratories as quality control material to verify the performance of staining reagents used in cell culture assays for the detection of HSV-1. Not for use in direct patient diagnosis.

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 16 '97 11:12AM PHONE NUMBER 403 37 403 101 101
P. 3/3

JUL 1 1997

# Class III Summary

## Type of Problems:

1. Loss of biological activity caused by antigenic deterioration.

2. Loss (Removal) of the fixed cells in either the infected or uninfected slide wells.

HSV-1 Antigen Control slides are to be used by laboratories to determine the activity of staining reagents. If the HSV-1 Antigen Control Slides had deteriorated to a point of non-reactivity or the cells had dislodged and were subsequently used by a laboratory, the indication would be that the staining reagents were not working properly. This would cause the test to be discarded but would not lead to a false positive or false negative clinical test result.

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MAR 10 '97 01:11PM VIRAL ANTIGENS, INC 901-382-6227
P.2/3

viral antigens Inc.
5171 Wilfong Road, Memphis, Tennessee 38134-5611 Phone [phone]
FAX [phone]

# Class III Certification

Date 3-10-97

510(k) Reference Number - K964874

Device name: HSV-1 Antigen Control Slides

I certify, that in my capacity as Vice President of Regulatory Affairs, of Viral Antigens, Inc. that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for HSV-1 Antigen Control Slides. I further certify that I am aware of the types of problems to which HSV-1 Antigen Control Slides is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about HSV-1 Antigen Control Slides is complete and accurate.


Terry S. Ratcliffe
VP Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Terry S. Ratcliffe
Vice President Regulatory Affairs
Viral Antigens, Inc.
5171 Wilfong Road
Memphis, TN 38134

Re: K964874
Trade Name: HSV-1 Antigen Control Slides
Regulatory Class: III
Product Code: GQN
Dated: January 14, 1997
Received: January 15, 1997

Dear Mr. Ratcliffe:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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) Reference Number - K964874

Device name: HSV-1 Antigen Control Slides

## INDICATIONS FOR USE:

In order to confirm HSV-1 infections physicians frequently use tissue culture techniques. This involves obtaining patient samples, inoculation of these samples into established cell lines (Such as MRC-5 cells) and monitoring these cells for HSV-1 induced cytopathology. Frequently the cells inoculated with patient sample are then stained as an aid in the diagnosis of HSV-1 infections.

HSV-1 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-1. Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well. The two wells of cells on the HSV-1 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.


Prescription Use (Per 21 CFR 801.109)

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