(41 days)
Not Found
Not Found
No
The summary describes a laboratory assay (ELISA) for detecting antibodies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description of the device's function is purely based on biochemical reactions.
No
The device is an in vitro diagnostic test system for detecting antibodies, intended as an aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the test system is "intended to be used as an aid in the diagnosis of infectious mononucleosis."
No
The device description is not found, but the intended use describes an "enzyme linked immunocorbent assay" which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly describes it as an "enzyme linked immunocorbent assay" that performs "qualitative detection of IgG antibodies to EBV-EA in human serum." This clearly indicates that it is a test performed on a biological sample (human serum) outside of the body to provide information for diagnosis. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This test system is an enzyme linked immunocorbent assay which provided a means for Use manual or automatod (Aptus), qualitative detection of IgG antibodies to EBV-EA in human serum. This test system is intended to be used as an ald in the diagricus's of infectious mononucloosis when used with other EBV serologies. The performarics 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
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 8 1998
Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08876
Re: K983804 Trade Name: Aptus (automated) Application for the EBV-EA IgG ELISA Regulatory Class: I Product Code: LSE
Dated: October 21, 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 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.
Image /page/0/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle-like emblem. The emblem is composed of three curved lines that suggest the wings and body of a bird in flight. The text is arranged in a circular pattern around the emblem.
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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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Page __
510(k) Number (if known): K983804
Aptus (automated) Application for the EBV-EA IgG ELISA Device Name: Test System
Indications for Use:
This lest system is an enzyme linked immunocorbent assay which provided a means for Use manual or automatod (Aptus), qualitative detection of IgG antibodies to EBV-EA in human serum. This test system is intended to be used as an ald in the diagricus's of infectious mononucloosis when used with other EBV serologies. The performarics characteristics have not been established to aid in the diagnosis of acute IM.
Revised: 12-04-96
(PLEASE DO NOT WRITE BELOW THIS LINE - CON'I INUE ON ANOTHER PAGE IF NEEDED)
Concurrerice of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
Woody Dubois
(Optional Formal 1-
2-95)
510(k) Number
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