For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection.
For in vitro diagnostic use only.
A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

Device Description

The SeraQuest EB VCA IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

AI/ML Overview

The provided document describes the SeraQuest EB VCA IgM test, an enzyme immunoassay designed to detect IgM antibodies to Epstein-Barr virus capsid antigen in human serum. This diagnostic test aims to differentiate active or recent EBV infection from past infection.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity, specificity, or positive/negative predictive values. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device by comparing overall agreement.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (SeraQuest EB VCA IgM)
Overall Agreement	Substantial equivalence to predicate device (Gull Laboratories' EBV IgM ELISA)	94.8% (95% CI: 94.8% to 98.3%)

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

Sample Size: 157 specimens.
Data Provenance: "Archival Patient Specimens Tested at SeraQuest, Miami, FL". This indicates the data is retrospective and from the USA (Miami, FL).

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

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a predicate device (Gull Laboratories' EBV IgM ELISA), which acts as the reference for classification (positive, negative, equivocal).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple readers or experts to resolve discrepancies between the SeraQuest test and the predicate device. The results are presented as a direct comparison between the two tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The study is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

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

Yes, the study describes the standalone performance of the SeraQuest EB VCA IgM test. As an enzyme immunoassay, it produces a quantitative result (Index value) which is then interpreted qualitatively (positive, negative, equivocal) without direct human-in-the-loop performance during the result generation. The comparison is between the standalone performance of the new device and the standalone performance of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Gull Laboratories' EBV IgM ELISA test. The study evaluates the concordance of the SeraQuest test with this predicate rather than an independent, gold-standard ground truth like pathology or long-term clinical outcomes.

8. The Sample Size for the Training Set

The document does not specify a separate training set size. The 157 specimens are referred to as "archival patient specimens" used for the comparison study. As this is an immunoassay and not a machine learning algorithm in the modern sense that requires explicit "training," the concept of a separate training set is not directly applicable in the terms usually associated with AI/ML development. The "in-house standard" mentioned for assigning Index values to calibrators might involve some internal standardization, but it's not a training set in the context of supervised learning.

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

Given that a training set in the AI/ML context is not explicitly mentioned or relevant, the method for establishing its ground truth is not applicable here. The test performance is evaluated against the predicate device.

Summary

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FROM : Guest International, Inc.

APPENDIX 3. (revised)

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.

. K990977

6 1999 OCT -

510(k) SUMMARY

Applicant:	Quest International, Inc.1938 N.E. 148th TerraceNorth Miami, FL 33181
Registration No.	1061839
Contact Person:	Robert A. Cort, V.P., Quality Assurance
Telephone:	(305) 948-8788
Telefax:	(305) 948-4876
Manufacturing Site:	Same as above
Device:	SeraQuest® EB VCA IgM
Device Name:	Epstein-Barr virus serological reagents (21CFR § 866.3235)
Device Classification:	Class I (general controls)

Description:

The Calibrators in the SeraQuest EB VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Principle:

Diluted samples are incubated in wells coated with Epstein-Barr virus capsid antigen. Absorbents have been included in the Diluent to neutralize the affects of theumatoid factor and IQG antibody. Antibodies directed against Epstein-Barr virus capsid antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to Epstein-Barr virus capsid antigen are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.

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APPENDIX 3. (revised)

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. . ... .. . . . .

Intended Use:

For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.

Predicate Device:

The SeraQuest EB VCA IgM test is substantially equivalent in intended use and performance, to the Gull Laboratories' EBV IgM ELISA test, Gull Laboratories, Inc., Salt Lake City, Utan.

Summary of technological characteristics:

Characteristic	SeraQuest EB VCA IgM	Gull Laboratories ' EBV IgM ELISA
Description:	Enzyme Immunoassay	Enzyme Immunoassay
Intended Use:	The detection of IgMantibodies against Epstein-Barr virus capsid antigenin human serum.	The detection of IgMantibodies against Epstein-Barr virus capsid antigenin human serum.
Solid Phase:	Plastic Microwell	Plastic Microwell
Antigen :	Recombinant p18	Purified gp 125
Number of Incubation Periods:	Three	Three
Sample Dilution:	1:51	1:11
Sample IncubationDuration:	30 minutes	30 minutes
Incubation Temperature:	Room temperature	37 °C.
Ezyme-labeled Conjugate:
Antibody	Goat anti-human IgM	Goat anti-human IgM
Label	Alkaline phosphatase	Alkaline phosphatase
Conjugate Volume:	100 ul	100 ul
Conjugate IncubationDuration:	30 minutes	30 minutes
Substrate:	p-Nitrophenylphosphate	p-Nitrophenylphosphate

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PHONE NO. : 305 946 4876

APPENDIX 3. (revised) Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.

100 µl Subtrate Volume: 100 ul Substrate Incubation 30 minutes 30 minutes Duration: Stop Reagent: 0.5 M Trisodium 1.5 N NaOH phosphate Stop Reagent Volume: 100 ul 100 ul Spectrophotometric Readout: Spectrophotometric 405 nm 405 nm Summary of Clinical Testing:

Of the 157 specimens tested, 26 were positive, and 121 were negative in both the SeraQuest and Gull Laboratories tests (please see Table 1). Of the 10 remaining specimens which were negative by the Gull test, were positive by the SeraQuest test, and 5 specimens which were positive by the Gull test, were negative by the SeraQuest test. Two specimens gave equivocal results in the SeraQuest test and were negative by the Gull test.

Table 1.

Results of Tests of 157 Archival Patient Specimens Tested at SeraQuest, Miami. FL Using the SeraQuest EB VCA IgM Test and Gull Laboratories' EBV VCA IgM EIA Test.

Gull LABSEBV VCAIgM	SeraQuest EB VCA IgM
	Positive	Negative	Equivocal	Total
Positive	26	5	0	31
Negative	3	121	2	126
Equivocal	0	0	0	0
Total	29	126	2	157

Overall agreement [ (TP + TN) / (TP + TN + FP + FN ) ] = 94.8 % * 95 % Cl = 94.8 to 98.3 % v

Excluding equivocal results

Calculated by the normal method.

Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750, 1986.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is black.

OCT 6 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181

K990977 Re: Trade Name: SeraQuest EB VCA IgM Regulatory Class: I Product Code: LJN Dated: July 30, 1999 Received: August 2, 1999

Dear Mr. Cort:

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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.

APPENDIX 6 (revised)

Page 1 of 1

K990977 510(k) Number (if known): _

Device Name: SeraQuest EB VCA IgM

Indications For Use:

1. For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection.
1. For in vitro diagnostic use only.
1. A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.

: : - - : : : :
: : : : : : : :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990977

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).