(54 days)
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Not Found
No
The summary describes a qualitative serological test for EBV antibodies and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: The device is an in vitro diagnostic test system for detecting antibodies, which is used to aid in diagnosis and provide information, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test system "may aid in the diagnosis and provide information on infectious mononucleosis."
No
The description clearly states the device is a "test system" for the detection of antibodies in human serum specimens, indicating it is an in vitro diagnostic device that likely involves physical reagents and laboratory equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens." This describes a test performed on a biological sample (human serum) outside of the body.
- "The test is for in vitro diagnostic use," This directly confirms its intended use as an in vitro diagnostic device.
The "Intended User / Care Setting" also reinforces this by stating "in vitro diagnostic use".
N/A
Intended Use / Indications for Use
This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use,
Product codes
83MCD
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.
JAN 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific. Inc. 200 Evans Wav Branchburg, NJ 08876
Re: K984126
Trade Name: The Aptus (automated) Application of the EBV-VCA IgG ELISA Test System Regulatory Class: I Product Code: 83MCD Dated: November 16, 1998 Received: November 18, 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 vour 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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _ K984126
Device Name: Aptus (automated) Application for the VCA IgG ELISA Test System
Indications for Use:
This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use,
Revised: 12-2-98
(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 CFR 801,109)
2-96)
Woody Dubois
(Optional Format 1-