← Product Code [LGC](/submissions/MI/subpart-d%E2%80%94serological-reagents/LGC) · K983886 # POCKIT HSV 2 RAPID TEST (K983886) _Diagnology , Ltd. · LGC · Aug 19, 1999 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LGC/K983886 ## Device Facts - **Applicant:** Diagnology , Ltd. - **Product Code:** [LGC](/submissions/MI/subpart-d%E2%80%94serological-reagents/LGC.md) - **Decision Date:** Aug 19, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3305 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state. PRECAUTION: The POCkit™ HSV-2 Rapid Test is intended for use in a high prevalence population, e.g. sexually active adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use. The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population e.g. prenatal patients, on immunocompromised individuals, for prenatal or neonatal screening, on other patients with HSV associated diseases, or for early stages of HSV seroconversion. ## Device Story POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for detecting IgG antibodies to HSV-2. Input: capillary whole blood (fingerstick) or serum. Principle: membrane-based immunoassay using specific antibody binding protein conjugated to colloidal gold particles and semi-purified HSV-2 glycoprotein G2 antigen. Test window contains a TEST spot (HSV-2 antigen) and a CONTROL spot (human IgG). When sample passes through membrane, anti-HSV-2 antibodies bind to TEST spot; developing reagent reacts with human IgG to produce pink/red color at both spots. Used at point-of-care by health professionals. Output: visual color change indicating presence of antibodies. Assists clinicians in diagnosing previous HSV-2 infection; does not distinguish between latent or active states. Benefits patient by providing rapid serological assessment in high-prevalence clinical settings. ## Clinical Evidence Clinical evaluation included 1193 whole blood samples and 1220 serum samples. Performance was evaluated relative to the HSV-2 Western Blot method. The CDC serum panel for HSV-2 serology was also tested. No specific sensitivity/specificity percentages or p-values were provided in the summary text. ## Technological Characteristics Membrane-based qualitative immunoassay. Components: solid phase membrane, wicking material, plastic housing. Reagents: antibody binding protein conjugated to colloidal gold, semi-purified HSV-2 glycoprotein G2 antigen, human IgG control. Manual, point-of-care test. No electronic components or software. ## 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). ## Predicate Devices - Gull HSV-2 IgG ELISA test ## Reference Devices - Western Blot HSV Type 2 ## 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}------------------------------------------------ 8/19/99 K983886 # 510(k) SUMMARY The assigned 510(k) number is: K983888 Applicant Informațion: | Date Prepared: | February 20, 1999 | |-------------------|-----------------------------------------------------------------------------------------------------| | Submitter's Name: | Diagnology Limited
Unit 5 Kennedy Enterprise Center
Blackstaff Road
Belfast, BT11 9DT U.K. | | Contact Organization: | Schiff & Company, Inc. | |-----------------------|------------------------| | Contact Person: | Dr. Robert Schiff | | Phone Number: | 973-227-1830 | | Fax Number: | 973-227-5330 | Device Information: | Trade Name: | POCkit™ HSV-2 Rapid Test | |----------------------|---------------------------------------------------| | Common Name: | Herpes simplex virus Type 2 Antibody Test | | Classification Name: | In vitro Diagnostic to detect antibodies to HSV-2 | # Equivalent Device Description: The device was found equivalent to Gull HSV-2 IgG ELISA test. Comparative testing was performed with Western Blot HSV Type 2. # Device Description: The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum. 2 {1}------------------------------------------------ ### Device Intended Use: The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoasaay The Founlitative determination, either in heparinized capillary whole blood taken lor the qualifiate acterim. of circulating IgG antibodies specific for herpes by inigerstick of in acturity of chocking to a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous tesung. The processes of may be of value in determination of previous Intection with PISV-2 and may bo of value in Seconsis of HSV associated disease. Immunological experience the to whether infection is currently in a latent or active state. #### PRECAUTION: The POCkit™ HSV-2 Rapid Test is intended for use in a high provalence ITHE FOOK! - 1109-2 hope've adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use. The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population . . . prenatal patlents, on immunocompromised individuals, for prenatal or nonatal screening, on other patients with HSV associated diseases, or for sarly stages of HŠV seroconversion. ### Principle of the Procedure: The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window. When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human 3 \$\mathcal{H}\$ {2}------------------------------------------------ p.8 IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit. ### Performance Data: The POCklt™ HSV-2 Rapid Test was evaluated relative to the HSV-2 Western Blot method. In addition, the CDC serum panel for HSV-2 serology assays was tested with this device. A total of 1193 whole blood samples and 1220 serum samples were evaluated. These results are shown in the tables 1,2 and 3 below. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three stripes above it, symbolizing health and human services. The text "DEPT. OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is black and white and appears to be a scanned image. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG 1 9 1999 bragnology Ltd. Dr. Robert Schiff c/o Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006 K983886 Re: Trade Name: POCkit™ HSV-2 Rapid Test Regulatory Class: III Product Code: LGC Dated: June 4, 1999 Received: June 7, 1999 # Dear Dr. Schiff: We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your bootion by o(x) ce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate use stated in the eneround, to regard the enactment date of the Medical Device Amendments, commence proof to May 20, 1976, ais editor with the provisions of the Federal For to devices mat nave been ot (Act). You may, therefore, market the device, subject to the I ood, Drug, and Cosmitons of the Act. The general controls provisions of the Act include general controls 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 (1 remarket / tpproval), it ins / see can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Furrent Good Manufacturing Practice requirements, as set forth in the Quality System Ourchil Good Manical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such through performs QB inspections).ith the GMP regulation may result in regulatory action. In assumptions. I andre to compts here announcements concerning your device in the Federal addition, I Dri may packist 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. {4}------------------------------------------------ Dage 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 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 2 {5}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT 510(K) NUMBER: K983886 DEVICE NAME: POCkit™ HSV-2 Rapid Test ## Indications for Use: The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state. #### PRECAUTION: : The POCkit™ HSV-2 Rapid Test is intended for use in a high prevalence population, e.g. sexually active adults and sexually transmitted disease clinic. If used in a low prevalence population, positive results should be considered presumptive and should be confirmed with an alternate methodology e.g. Western blot. Assay results are not intended for medical/legal use. The POCkit™ HSV-2 Rapid Test is not recommended as a screening procedure for the general population of for testing in a prenatal, pediatric or neonatal population. Performance characteristics have not been established in a low prevalence population e.g. prenatal patients, on Immunocompromised individuals, for prenatal or neonatal screening, on other patients with HSV associated diseases, or for early stages of HSV seroconversion. Woody Dubois icinn Sion. ivision of Clin 510(k) Number OR Prescription Use (Per 21 CFR 801.109) Over-The Counter Use (Optional Format 1-2-96) ﻠﺴ --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LGC/K983886](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LGC/K983886) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com