IMMUNOWELL EBNA IGG TEST

{0}------------------------------------------------ # AUG 1 0 1998 # 510(k) Summary | Contact | Bryan Kiehl | |-----------|------------------------------------------------------------| | Address | GenBio<br>15222-A Avenue of Science<br>San Diego, CA 92128 | | Telephone | (619) 592-9300 ext 309 | | FAX | (619) 592-9400 | | Email | BKiehl@GenBio.com | | Date: | 10 August, 1998 | | Device Name | Immuno WELL EBNA IgG Test | |---------------------------------------|---------------------------------------------| | Common, usual, or classification name | Epstein-Barr Virus Nuclear Antigen IgG Test | | Classification Number (if known) | 866.3235 | ## Identification of the legally marketed device substantial equivalence is claimed: Ebstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit, Gull Laboratories, Inc. Description of the new device: Microtiter ELISA kit detecting EBNA antibodies ### Intended Use of New Device: InmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the BBV viral capsid IgG or IgM, ERV early antigen IgG tests and/or heterophile tests, The results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children. ## Technological characteristics of the new device compared to the predicate device: The new device and the predicate ElA device are essentially identical. Both use EBNA-1 recombinant antigen and measure antibiodies in a microtiter assay format using ELISA technology. Non-clinical performance data, the summary includes a brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence. ImmunoWELL EBNA IgG Test Page 1 {1}------------------------------------------------ The predicate device and the new device perform essentially the same when testing sers from suspected patients. The observations are: #### Table 1: Gull ElA | | | Alternate EIA | | | |------------|-------------------|---------------|---------|-------------------| | | | Past/Recent | Current | No Past Infection | | ImmunoWELL | Past/Recent | 65 | 8 | 0 | | | Current | 0 | 7 | 0 | | | No Past Infection | 5 | 1 | 8 | ## Clinical performance data, the summary includes a brief discussion of clinical tests and how their results support a determination of substantial equivalence. The device used in conjunction with other ImmunoWFIJ. EBV assays (VCA IgG and VCA IgM) provides clinical information that is substantially the same as serological information using the predicate device. #### The summary includes the conclusions drawn from the nonclinical and clinical tests. This assay yields results that are essentially the same the predicate device. #### Immuno WELL EBNA IgG Test Page 2 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing strokes, symbolizing health and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG | 0 |998 Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128 Re : K973941/S2 > Trade Name: ImmunoWELL® EBV EBNA IgG Test Regulatory Class: I Product Code: LLM Dated: May 15, 1998 Received: May 19, 1998 Dear Dr. Kiehl: 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 Requlations, 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 requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. {3}------------------------------------------------ #### Paqe 2 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, "Misbrandinq 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 (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {4}------------------------------------------------ FDA Document Number: ## Indications for Use 510(k) Number (if known): K973941 Device Name: ImmunoWELL EBNA Test Indications for Use: ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children. > (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Woodley Dubois (Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number K973941 Prescription Use > (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)