ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Device Description

Microtiter ELISA kit detecting VCA IgM antibodies

AI/ML Overview

This document describes the ImmunoWELL VCA IgM Test, a microtiter ELISA kit designed for the qualitative detection of IgM antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum. This test is intended to be used as an aid in diagnosing infectious mononucleosis (IM) when used alongside other EBV tests.

The submission claims substantial equivalence to the Epstein-Barr Viral Capsid Antigen IgM ELISA Kit by Gull Laboratories, Inc. Both devices utilize VCA affinity-purified antigen and measure antibodies using ELISA technology in a microtiter assay format.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity thresholds). Instead, the study's goal was to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of agreement with the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance (ImmunoWELL VCA IgM Test vs. Gull EIA)
Substantial equivalence in performance to the predicate device.	Negative Agreement: 88 out of 89 samples (98.9%) were negative by both devices.
	Positive Agreement: 4 out of 5 samples (80%) were positive by both devices.
	Overall Agreement: 92 out of 94 samples (97.9%) showed agreement.

Note: The table presented in the input is a 2x2 contingency table comparing the ImmunoWELL VCA IgM Test (labeled "GB") against the Gull EIA.

Table 1: Gull EIA		Gull EIA
ImmunoWELL		Negative	Positive
	Negative	88	1
	Positive	0	4

From this table:

True Negatives (both negative): 88
False Negatives (ImmunoWELL negative, Gull positive): 1
False Positives (ImmunoWELL positive, Gull negative): 0
True Positives (both positive): 4

This implies:

Total Gull Negative: 88
Total Gull Positive: 5 (4+1)
Total ImmunoWELL Negative: 89 (88+1)
Total ImmunoWELL Positive: 4

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: 93 samples (88 negative by predicate + 4 positive by predicate + 1 discrepant). The table shows a total of 93 samples analyzed in the comparison study.
Data Provenance: The document does not explicitly state the country of origin. It mentions "sera from suspected patients," suggesting these were patient samples collected in a clinical context. The study is retrospective, as it involves testing existing serum samples and comparing the results to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" and their qualifications for establishing ground truth is not applicable in this context. The "ground truth" for the test set is established by the results of the predicate device (Gull Laboratories' Epstein-Barr Viral Capsid Antigen IgM ELISA Kit). The study design compares the new device's results against those of an already legally marketed device, considering the predicate device's results as the reference.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison is a direct concordance analysis between the new device and the predicate device. Discrepancies (one sample was negative by ImmunoWELL but positive by Gull EIA) are noted, but no further adjudication (e.g., by a third expert or a tie-breaker rule) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a diagnostic kit, not on the interpretation skills of human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this is a standalone study of the device (ELISA kit). The performance reported is that of the ImmunoWELL VCA IgM Test kit itself, without human interpretation as a variable. The "human-in-the-loop" concept is more relevant to imaging or AI-assisted diagnostic systems.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the ImmunoWELL VCA IgM Test was comparison to a legally marketed predicate device (Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.). The predicate device's results served as the reference standard for assessing the new device's performance.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This type of diagnostic device (ELISA kit) typically undergoes development and validation using laboratory methods, rather than machine learning training sets. Therefore, there's no mention of a traditional "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of this device's development (which is assumed to be a traditional ELISA kit development rather than an AI algorithm), the establishment of ground truth for a training set is not applicable or described in the provided text.

Summary

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AUG 10 1998 510(k) Summary

Contact	Bryan Kiehl
Address	GenBio15222-A Avenue of ScienceSan Diego, CA 92128
Telephone	(619) 592-9300 ext 309
FAX	(619) 592-9400
Email	BKiehl@GenBio.com
Date:	10 August, 1998

Device Name	ImmunoWELL VCA IgM Test
Common, usual, or classification name	Epstein-Barr Virus Viral Capsid Antigen IgM Test
Classification Number (if known)	866.3235

Identification of the legally marketed device substantial equivalence is claimed:

Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.

Description of the new device:

Microtiter ELISA kit detecting VCA IgM antibodies

Intended Use of New Device:

ImmowELL VCA IgM Test is for the qualitative detection of IgM antibudy to Epstein-Barr Vinis viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and FRV early antigen tests and/or heteryphile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Technological characteristics of the new device compared to the predicate device:

The new device and the predicate £1A device are essentially identical. Both use VCA affinity purified antigen and measure antibodies in a microtiter assay format using ELISA technology.

Non-clinical performance data, the summary includes a brief discussion of the nonclinical tests and how their results support a determination of substantial equivalence.

The predicate device and the new device perform essentially the same when testing sera from suspected patients. The observations are:

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Table 1: Gull EIA
EIA
		Negative	Positive
GB	Negative	88	1
	Positive	0	4

Clinical performance data, the summary includes a brief discussion of clinical tests and how their results support a determination of substantial equivalence.

The device used in conjunction with other ImmunoWELL EBV assays (EBNA IgG and VCA IgG) provides clinical information that is substantially the same as serological information using the predicate device.

The summary includes the conclusions drawn from the nonclinical and clinical tests.

This assay yields results that are essentially the same the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

.AUG 10 1998

Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128

Re : K973939/S2 Trade Name: ImmunoWELL® EBV VCA IgM Test Regulatory Class: I Product Code: LJN Dated: May 15, 1998 Received: May 19, 1998

Dear Dr. Kiehl:

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, Druq, 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 reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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FDA Document Number:

Indications for Use

510(k) Number (if known): K973939

Device Name: ImmunoWELL VCA IgM Test

Indications for Use: ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodey Aubain
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K973939

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).