← Product Code [LSE](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE) · K983801 # THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983801) _Zeus Scientific, Inc. · LSE · Dec 10, 1998 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983801 ## Device Facts - **Applicant:** Zeus Scientific, Inc. - **Product Code:** [LSE](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE.md) - **Decision Date:** Dec 10, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3235 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for Use The test system is an enzyme-linked immunosorbent assay designed for the manual or automated (Aptus) qualitative detection of IgM class antibodies to EBV-VCA in human serum. The test system is intended to be used for the diagnosis of EBV-associated infectious mononucleosis (IM) when used in conjunction with other EBV serologies. ## Device Story The Aptus system is an automated enzyme-linked immunosorbent assay (ELISA) platform designed for clinical laboratory use. It processes human serum samples to detect IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA). The device automates the standard ELISA workflow, which involves reagent dispensing, incubation, washing, and optical density measurement. The system provides qualitative results to clinicians to assist in the diagnosis of infectious mononucleosis. By automating the manual ELISA process, the device increases laboratory throughput and reduces manual handling errors, supporting faster clinical decision-making for patients presenting with symptoms of mononucleosis. ## Clinical Evidence No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use. ## Technological Characteristics Enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgM antibodies. The system supports both manual and automated (Aptus) processing. It functions as an in vitro diagnostic test system. ## Regulatory Identification Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer). ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 0 1998 Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08876 Re: K983801 Trade Name: Aptus (automated) Application for the EBV-VCA IgM ELISA Regulatory Class: I Product Code: LSE Dated: October 23, 1998 Received: October 28, 1998 Dear Mr. Kopnitsky: 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 Regulations. 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 regulation (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 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 Jaws 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 Sutman 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}------------------------------------------------ Page of 510(k) Number (if known): _ K983801 Device Name: Aptus (automated) Application for the EBV-VCA IgM ELISA Test System Indications for Use: The test system is an enzyme-linked immunosorbent assay designed for the manual or automated (Aptus) qualitative detection of IgM class antibodies to EBV-VCA in human serum. The test system is intended to be used for the diagnosis of EBV-associated infectious mononucleosis (IM) when used in conjunction with other EBV serologies. " (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CHK 801, 109) Dubois (" (Optional Formar 1- 2-96) Division of Clinical Laboratory Devices 510(k) Number 1 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983801](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983801) **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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