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.

Device Description

The SeraQuest 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 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

Here's a breakdown of the acceptance criteria and study details for the SeraQuest® VCA IgM device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the SeraQuest® VCA IgM device beyond the 'Overall agreement' percentage. It primarily demonstrates substantial equivalence to a predicate device using comparative clinical testing.

Table 1. SeraQuest® VCA IgM Performance Against Zeus' EBV-VCA IgM EIA Test

Metric	Acceptance Criteria (Implied)	Reported Performance (SeraQuest® VCA IgM)
Overall Agreement	Not explicitly stated	99.0 %
95% Confidence Interval	Not explicitly stated	97.3 to 100 %

Note: The acceptance criteria here are inferred from the reported overall agreement, as no specific quantitative thresholds were explicitly defined in the document for FDA clearance.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 113 specimens
- Data Provenance: Archival patient specimens tested at SeraQuest, Miami, FL (United States). The study is retrospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications used to establish the ground truth. Instead, the predicate device (Zeus' EBV-VCA IgM ELISA test) served as the comparator for the test set.
Adjudication Method:
- The document does not describe a specific adjudication method such as 2+1 or 3+1. The results of the SeraQuest test were directly compared against the results of the Zeus' EBV-VCA IgM ELISA test.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This study is a comparison of a new diagnostic device against a predicate device, not a study of human reader improvement with or without AI assistance.
Standalone Performance Study:
- Yes, a standalone performance study was conducted. The SeraQuest VCA IgM device's performance was evaluated by testing 113 archival patient specimens and comparing its results directly with those obtained from the predicate device (Zeus' EBV-VCA IgM ELISA test). This represents the algorithm/device's performance without human intervention in the result interpretation beyond what is inherent in reading an EIA test.
Type of Ground Truth Used:
- The "ground truth" for this study was established by the results obtained from the predicate device, Zeus' EBV-VCA IgM ELISA test. This is a comparative study where the predicate device's results serve as the reference.
Sample Size for the Training Set:
- The document does not provide information on a training set or its sample size. As this is a diagnostic device comparison for substantial equivalence, it's likely a fully developed product was tested, not one undergoing a machine learning training phase.
How the Ground Truth for the Training Set was Established:
- Since no training set information is provided, the method for establishing its ground truth is also not available.

Summary

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JAN 1 5 2004	510(k) SUMMARY	K033780
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® VCA IgM
Device Name:	Epstein-Barr virus serological reagents (21CFR § 866.3235)
Device Classification:	Class I (general controls)

Description:

The Calibrators in the SeraQuest 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 rheumatoid factor and IgG antibody. Antibodies directed against Epstein-Barr virus capsid antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to Epstein-Barr virus capsid antigen are present, the coniugate 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 vellow end-product which is read photometrically at 405 nm.

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Intended Use:

Predicate Device:

The SeraQuest VCA IgM test is substantially equivalent in intended use and performance, to the Zeus' EBV IgM ELISA test, Zeus Scientific, Inc., Raritan, New Jersey. 08869.

Summary of technological characteristics:

Characteristic	SeraQuest VCA IgM	Zeus' EBV-VCA IgM ELISA
Description:	Enzyme Immunoassay	Enzyme Immunoassay
Intended Use:	The detection of IaMantibodies 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 :	Purified gp125	Purified gp 125
Number of Incubation Periods:	Three	Three
Sample Dilution:	1:51	1:21
Sample IncubationDuration:	30 minutes	25 minutes
Incubation Temperature:Ezyme-labeled Conjugate:	Room temperature	Room temperature
Antibodv	Goat anti-human IgM	Goat anti-human IgM
Label	Alkaline phosphatase	Horseradish Peroxidase
Conjugate Volume:	100 µl	100 ul
Conjugate IncubationDuration:	30 minutes	25 minutes

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Quest International, Inc. 1938 N.E. 148th Terrace, N. Miami, Fl. 33181ATTACHMENT 5	Page No. 18
Substrate:	p-Nitrophenylphosphate	TMB
Subtrate Volume:	100 μl	100 μl
Substrate IncubationDuration:	30 minutes	10 minutes
Stop Reagent:	0.5 M Trisodiumphosphate	1M H2SO4,0.7M HCL
Stop Reagent Volume:	100 μl	50 μl
Readout:	Spectrophotometric405 nm	Spectrophotometric450 nm

Summary of Clinical Testing:

Of the 113 specimens tested, 18 were positive, and 91 were negative in both the SeraQuest and Zeus' VCA IgM tests (please see Table 1). Of the 4 remaining specimens, 2 specimens which were positive by the Zeus' test, one was negative and the other equivocal by the SeraQuest test. One specimen which was equivocal by the Zeus' test, was negative by the SeraQuest test. One specimen which was negative by the Zeus' test, was equivocal by the SeraQuest test.

Table 1.

Results of Tests of 113 Archival Patient Specimens Tested at SeraQuest, Miami, FL, Using the SeraQuest EB VCA IgM Test and the Zeus EBV VCA IgM EIA Test.

	SeraQuest VCA IgM
ZeusEBV-VCA IgM	Positive	Negative	Equivocal	Total
Positive	18	1	1	20
Negative	0	91	1	92
Equivocal	-	1	-	1
Total	18	93	2	113

Overall agreement [ (TP + TN) / (TP + TN + FP + FN ) ] = 99.0 % * 95 % CI = 97.3 to 100 % **

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, 198

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

JAN 1 5 2004

Mr. Robert A. Cort V. P., Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181

Re: K033780

Trade/Device Name: SeraQuest® VCA IgM Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LJN Dated: November 26, 2003 Received: December 16, 2003

Dear Mr. Cort:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may) aters, and second in 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that 119 Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and The FDA finding of substantial equivalence of your device to a legally premaince revilledied. to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of of questions on the provice Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer 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,

Saqartys

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name __ SeraQuest EB VCA IgM

Indications for Use:

1. For In Vitro Diagnostic Use
1. For the qualitative detection of human IgM antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay, as viral oupold antigoritiating active or recent Epstein-Barr virus infection from past infection.
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.

Prescription Use
(Part 21 CFR Subpart D)

Over-The-Counter-Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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KO33780 -510(k)________________________________________________________________________________________________________________________________________________________________________

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).