← Product Code [GQN](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQN) · K971101 # HSV-2 ANTIGEN CONTROL SLIDES (K971101) _Viral Antigens, Inc. · GQN · Jul 1, 1997 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQN/K971101 ## Device Facts - **Applicant:** Viral Antigens, Inc. - **Product Code:** [GQN](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQN.md) - **Decision Date:** Jul 1, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3305 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use HSV-2 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-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the HSV-2 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-2 Antigen Control Slides serve as quality control tools for clinical laboratory personnel performing HSV-2 confirmatory assays. Slides contain two wells of fixed cells: one HSV-2 infected, one uninfected. During patient sample testing, these slides are stained alongside patient-inoculated cell cultures. The positive well confirms staining reagent efficacy; the negative well monitors for non-specific staining. Failure to stain the positive well alerts the technician to reagent or procedural errors. This ensures accuracy in identifying HSV-2 induced cytopathology in patient samples, supporting clinical diagnosis of HSV-2 infections. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Fixed cell-based control slides containing HSV-2 infected and uninfected wells. Designed for manual staining procedures in clinical laboratory settings. No electronic components, software, or energy sources. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 JUL 1 1997 Re: K971101 Trade Name: HSV-2 Antigen Control Slides Regulatory Class: III Product Code: GQN Dated: March 25, 1997 Received: March 26, 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. {1} Page 2 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 (770)488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 {2} 510(k) Reference Number - To be assigned Device name: HSV-2 Antigen Control Slides ## INDICATIONS FOR USE: In order to confirm HSV-2 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-2 induced cytopathology. Frequently the cells inoculated with patient sample are then stained as an aid in the diagnosis of HSV-2 infections. **HSV-2 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-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the **HSV-2 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. Phaconlansed (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K971101 Prescription use X Page 10 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQN/K971101](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQN/K971101) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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