MODIFICATION TO SERAQUEST VCA IGM

K033780 · Quest Intl., Inc. · LJN · Jan 15, 2004 · Microbiology

Device Facts

• Record ID: K033780
• Device Name: MODIFICATION TO SERAQUEST VCA IGM
• Applicant: Quest Intl., Inc.
• Product Code: LJN · Microbiology
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

The SeraQuest EB VCA IgM assay is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) in human serum. It is intended for use as an aid in the diagnosis of acute or recent Epstein-Barr virus infection.

Device Story

SeraQuest VCA IgM is a solid-phase enzyme immunoassay (EIA) for detecting IgM antibodies against EBV capsid antigen in human serum. Input: human serum samples. Process: samples incubated in microwells coated with purified gp125 antigen; rheumatoid factor/IgG neutralized by absorbents in diluent; immobilized IgM antibodies detected via goat anti-human IgM conjugate labeled with alkaline phosphatase; substrate (p-Nitrophenyl phosphate) added, producing yellow end-product. Output: photometric reading at 405 nm converted to Index values. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing acute or recent EBV infection.

Clinical Evidence

Clinical evaluation compared SeraQuest VCA IgM against the Zeus EBV-VCA IgM ELISA using 113 archival patient specimens. Results showed 18 positive and 91 negative in both tests. Overall agreement was 99.0% (95% CI: 97.3–100%) excluding equivocal results. No clinical prospective data provided.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) using plastic microwells. Antigen: purified gp125. Conjugate: goat anti-human IgM labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Stop reagent: 0.5 M Trisodium phosphate. Readout: spectrophotometric at 405 nm. Manual or automated incubation/washing process.

Indications for Use

Indicated for qualitative detection of human IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) in human serum to aid in differentiating active/recent infection from past infection. Positive results are presumptive for anti-EBV IgM and acute/recent EBV infection.

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 IgM ELISA test (K033780)

Submission Summary (Full Text)

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

#### 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.

### 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:

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 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 IaM<br>antibodies against Epstein-<br>Barr virus capsid antigen<br>in human serum. | The detection of IgM<br>antibodies against Epstein-<br>Barr virus capsid antigen<br>in 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 Incubation<br>Duration: | 30 minutes | 25 minutes | |
| Incubation Temperature:<br>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 Incubation<br>Duration: | 30 minutes | 25 minutes | |

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| Quest International, Inc. 1938 N.E. 148th Terrace, N. Miami, Fl. 33181<br>ATTACHMENT 5 | Page No. 18 | |
|----------------------------------------------------------------------------------------|------------------------------|------------------------------|
| Substrate: | p-Nitrophenyl<br>phosphate | TMB |
| Subtrate Volume: | 100 μl | 100 μl |
| Substrate Incubation<br>Duration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodium<br>phosphate | 1M H2SO4,0.7M 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, 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 | | | |
|---------------------|-------------------|----------|-----------|-------|
| Zeus<br>EBV-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 [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 Tou may of Small 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,

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
- 2. 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) |

OR

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

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