MODIFICATION TO SERAQUEST EB VCA IGG

K033915 · Quest Intl., Inc. · LSE · Jan 16, 2004 · Microbiology

Device Facts

• Record ID: K033915
• Device Name: MODIFICATION TO SERAQUEST EB VCA IGG
• Applicant: Quest Intl., Inc.
• Product Code: LSE · Microbiology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

The EB VCA IgG test is intended for the qualitive and semi-quantative detection of human IgG antibodies to Epstein-Barr viral capsid antigen, in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest EB VCA IgG is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against Epstein-Barr virus capsid antigen in human serum. The test uses microwells coated with inactivated EB VCA virus. Patient serum is incubated in wells; if IgG antibodies are present, they bind to the antigen. After washing, goat anti-human IgG conjugated with alkaline phosphatase is added. A substrate (p-Nitrophenyl phosphate) is added, producing a yellow end-product measured photometrically at 405 nm. The device is intended for manual use or with the HyPrep System Plus in clinical laboratory settings. Results are reported as Index values based on in-house calibrators. The assay aids clinicians in distinguishing between active/recent and past EBV infections.

Clinical Evidence

Clinical performance evaluated by comparing 113 serum samples against the Zeus EBV VCA IgG test. Results showed 61 positive and 36 negative concordant results. Excluding equivocal results, the overall agreement was 90.7% (95% CI: 85.1-96.2%).

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) in plastic microwells. Antigen: Inactivated EB VCA virus. Conjugate: Goat anti-human IgG labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Readout: Spectrophotometric at 405 nm. Manual or automated (HyPrep System Plus) operation. Room temperature incubation.

Indications for Use

Indicated for qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr viral capsid antigen in human serum. Used as an aid in differentiating active or recent EBV infection from past infection. For in vitro diagnostic use.

Regulatory Classification

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).

Predicate Devices

• Zeus EBV VCA IgG Test System (Zeus Scientific, Inc.)

Submission Summary (Full Text)

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KO33915

| JAN 1 6 2004 | 510(k) SUMMARY |
|------------------------|--------------------------------------------------------------------------------|
| Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL. 33181 |
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, V.P. , Quality Assurance |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® EB VCA IgG |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |

## Description

The SeraQuest EB VCA IgG 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 IgG antibodies which are directed against Epstein-Barr virus capsid antigen, in human serum.

The Calibrators in the SeraQuest EB VCA IgG 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. 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 IgG) is added and incubated. If IgG 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.

### Intended Use

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Intended Use: The EB VCA IgG test is intended for the qualitive and semi-quantative detection of human IgG antibodies to Epstein-Barr viral capsid antigen, in human serum by enzyme

immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

## Predicate Device

The SeraQuest EB VCA IgG test is substantially equivalent in intended use and performance, to the Zeus EBV VCA IgG Test System, Zeus Scientific, Inc. Raritan, New Jersey. 08869.

## Summary of technological characteristics

| Characteristic | SeraQuest EB VCA IgG | Zeus ' EBV-VCA IgG ELISA |
|-----------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG<br>antibodies against Epstein-<br>Barr virus capsid antigen<br>in human serum. | The detection of IgG<br>antibodies against Epstein<br>Barr virus capsid antigen<br>in human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen : | Inactivated EB VCA virus | Inactivated EB VCA virus |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:21 |
| Sample Incubation Duration: | 30 minutes | 25 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Horseradish Peroxidase |
| Conjugate Volume: | 100 μl | 100 μl |
| Conjugate Incubation Duration: | 30 minutes | 25 minutes |

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| Quest International, Inc. 1938 N.E. 148th Terrace, N. Miami, Fl. 33181<br>APPENDIX 5 | | Page No. 17 |
|--------------------------------------------------------------------------------------|------------------------------|------------------------------|
| Substrate: | p-Nitrophenyl phosphate | TMB |
| Subtrate Volume: | 100 µl | 100 µl |
| Substrate Incubation Duration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodium Phosphate | 1M H2SO4, 0.7 M HCl |
| Stop Reagent Volume: | 100 µl | 50 µl |
| Readout: | Spectrophotometric<br>405 nm | Spectrophotometric<br>450 nm |

#### Summary of Clinical Testing

Of the 113 specimens tested, 61 were positive, and 36 were negative in both the SeraQuest and Zeus' VCA IgG tests. Of the 16 remaining specimens, 13 specimens which were positive by the Zeus' test, eight were negative and five equivocal by the SeraQuest test. One specimen which was equivocal by the Zeus' test, was negative by the SeraQuest test. Two specimens which were negative by the Zeus' test, were positive by the SeraQuest test. Excluding the equivocal results, the performance characteristics of the SeraQuest VCA IgG test (modified device) relative to Zeus' VCA IqG test were as follows. Please see Table 1 below.

#### TABLE 1.

## RESULTS OF SeraQuest VCA IgG ASSAYS (MODIFIED DEVICE) AND ZEUS VCA IgG ASSAYS ON 113 SERUM SAMPLES.

| Zeus<br>EBV-VCA IgG | SeraQuest VCA IgG | | | |
|---------------------|-------------------|----------|-----------|-------|
| | Positive | Negative | Equivocal | Total |
| Positive | 61 | 8 | 5 | 74 |
| Negative | 2 | 36 | - | 38 |
| Equivocal | - | 1 | - | 1 |
| Total | 63 | 45 | 5 | 113 |

Overall agreement [ (TP + TN) / (TP + TN + FP + FN ) ] = 90.7 % * 95 % Cl = 85.1-96.2 % **

- * 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

'JAN 1 6 2004

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

k033915 Re:

Trade/Device Name: SeraQuest EB VCA IgG Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LSE Dated: December 15, 2003 Received: December 18, 2003

Dear Mr. Cort:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 for about 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). and Cosmeter Fee (. 10.) market the device, subject to the general controls provisions of the Act. The rou may, ateres, 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 (PMA), it If your de rice 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 be found in The Layer 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 I 1971 has made a and regulations administered by other Federal agencies. You must or any I catal statuted and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 8077, abouting systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I this letter notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 I ou may of amall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

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

KO33915 510(k) Number

Device Name SeraQuest EB VCA IgG

Indications for Use:

- 1. For In Vitro Diagnostic Use
- 2. For the qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay.
- 3. For use as an aid in differentiating active or recent infection, from past infection.

Prescription Use √
(Part 21 CFR Subpart D)

OR

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

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

The Million of Children and the controlled on the man annual comments and considered

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 033915

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