(147 days)
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No
The document describes an in vitro diagnostic test for detecting antibodies to a virus and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test system designed to detect IgG antibodies to EBV EA in human serum specimens as an aid in the diagnosis of infectious mononucleosis. It does not treat or alleviate a disease, but rather provides diagnostic information.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis." This clearly indicates its role in diagnosis.
No
The device is an in vitro diagnostic (IVD) test system designed to detect antibodies in human serum specimens. This inherently involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test system is designed to detect IgG antibodies to EBV EA in human serum specimens and is intended to be used as an aid in the diagnosis of infectious mononucleosis. This involves testing a sample taken from the human body (serum) outside of the body to provide information for diagnosis.
- Sample Type: The device uses human serum specimens, which are biological samples taken from a patient.
- Purpose: The purpose is to aid in the diagnosis of a disease (infectious mononucleosis) by detecting specific antibodies in the sample.
These are all key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting Iymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. In underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic.
Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes which lasts probably for life. Reactivation of the latent viral carrier state, as evidenced by increased rates of virus shedding, is enhanced by immunosuppression, pregnancy, malnutrition or disease.
Antibody titers to specific EBV antigens correlate with different stages of infectious mononucleosis. Antibodies to EA may appear transiently for up to three months or longer during the acute phase of IM in 85% of patients. Antibodies to EA together with antibodies to EBNA and high titers of IgG to VCA may be associated with reactivation of the latent viral carrier state.
This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.
Product codes
LSE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3235 Epstein-Barr virus serological reagents.
(a)
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).(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
AUG 21 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Vice President, Research · and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876
Re: K981120
Trade Name: Zeus Scientific, Inc., anti-EBV EA IgG ELISA Test System Regulatory Class: I Product Code: LSE Dated: June 9, 1998 Received: June 10, 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 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 (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
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510(k) Number (if known). K981120
Zeus Scientific, Inc., anti-EBV EA IgG ELISA Test System Device Name:
Indications for Use:
Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting Iymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. In underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic.
Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes which lasts probably for life. Reactivation of the latent viral carrier state, as evidenced by increased rates of virus shedding, is enhanced by immunosuppression, pregnancy, malnutrition or disease.
Antibody titers to specific EBV antigens correlate with different stages of infectious mononucleosis. Antibodies to EA may appear transiently for up to three months or longer during the acute phase of IM in 85% of patients. Antibodies to EA together with antibodies to EBNA and high titers of IgG to VCA may be associated with reactivation of the latent viral carrier state.
This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubace
inical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801, 109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)