ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA by ZEUS SCIENTIFIC, INC.

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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. Therefore, it does not contain the detailed information required to answer all parts of your request about acceptance criteria and a study proving the device meets them.

However, based on the information provided in the document (specifically the "Indications for Use" from page 1 and the general nature of a 510(k) submission), I can infer some aspects and highlight what is not present:

Information available from the document:

Device Name: Zeus Scientific, Inc., anti-EBV EA IgG ELISA Test System
Intended Use: To detect IgG antibodies to EBV EA in human serum specimens. Intended to be used as an aid in the diagnosis of infectious mononucleosis.

Here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document is an FDA clearance letter confirming substantial equivalence to a predicate device, not a detailed technical report of the device's performance study. It does not contain tables of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy against a gold standard). The general assumption in a 510(k) is that the device performs "as well as" or "similarly to" the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not specify the sample size, type of study (retrospective/prospective), or data provenance for any clinical trial that may have been performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Cannot be provided directly. For an ELISA diagnostic test, "ground truth" is typically established by comparing results to a reference method or clinical diagnosis, not by expert consensus in the same way imaging studies are. The document doesn't detail how the ground truth for any validation samples was established or the number/qualifications of individuals involved.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. Adjudication methods like 2+1 or 3+1 are primarily relevant for subjective assessments, typically in imaging studies where discordant expert opinions need to be resolved. This is an ELISA test, which produces objective numerical results, so such adjudication is not generally used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic (IVD) ELISA test, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study. It provides a direct measurement (IgG antibody levels).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Partially applicable. An ELISA test is inherently a "standalone" assay in that the result is generated by the biochemical reaction of the test system, without real-time human input influencing the result generation itself. However, the document does not provide performance data for such a standalone assessment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be definitively stated from the document. For an ELISA for infectious disease, the ground truth would likely be established by a combination of:
  - Clinical diagnosis of infectious mononucleosis (based on symptoms, other lab tests).
  - Results from other established reference methods for EBV antibody detection.
  - Patient outcomes data (e.g., resolution of symptoms) might indirectly contribute, but less directly for establishing assay accuracy.
- The document states, "The performance characteristics have not been established to aid in the diagnosis of acute IM." This implies that the device's utility specifically for acute IM diagnosis was not fully proven by the submitted data for clearance.
The sample size for the training set:
- Not provided. This document does not mention a training set, as a traditional machine learning model would have. ELISA kits are developed through formulation and calibration, not typically "trained" on datasets in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the AI/ML sense is mentioned or implied for an ELISA test.

In summary: The provided document is an FDA clearance letter for a medical device (an ELISA test kit) that confirms its substantial equivalence to a legally marketed predicate device. It is not a detailed scientific study report that would contain the specific performance data, study methodologies, and ground truth establishment details you are asking for. Such information would typically be found in the manufacturer's 510(k) submission summary or detailed clinical study reports, which are not part of this public clearance letter.

Summary

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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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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

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Page 1

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubace

inical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801, 109)

Over-The-Counter Use __

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).