SERAQUEST EB VAC IGM

K990977 · Quest Intl., Inc. · LJN · Oct 6, 1999 · Microbiology

Device Facts

• Record ID: K990977
• Device Name: SERAQUEST EB VAC IGM
• Applicant: Quest Intl., Inc.
• Product Code: LJN · Microbiology
• Decision Date: Oct 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

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.

Device Story

SeraQuest EB VCA IgM is a solid-phase enzyme immunoassay (EIA) for detecting IgM antibodies against Epstein-Barr virus capsid antigen in human serum. Performed in microwells at room temperature; involves three 30-minute incubations. Samples are diluted and incubated in antigen-coated wells; absorbents in diluent neutralize rheumatoid factor and IgG. Immobilized antibodies are detected via enzyme-labeled goat anti-human IgM conjugate and p-Nitrophenyl phosphate substrate. Enzyme converts substrate to yellow end-product, measured photometrically at 405 nm. Results reported as Index values based on in-house standard. Used in clinical laboratory settings by trained personnel. Provides diagnostic aid for identifying active or recent Epstein-Barr virus infection.

Clinical Evidence

Clinical evaluation compared SeraQuest EB VCA IgM against Gull Laboratories' EBV IgM ELISA using 157 archival patient specimens. Results showed 26 true positives, 121 true negatives, 5 false positives, and 3 false negatives (excluding 2 equivocal results). Overall agreement was 94.8% (95% CI: 94.8% to 98.3%).

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) in plastic microwells. Antigen: recombinant p18. Conjugate: goat anti-human IgM labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Readout: spectrophotometric at 405 nm. Manual or automated incubation/wash steps. No software-based algorithm; results calculated via Index values against in-house standard.

Indications for Use

Indicated for qualitative detection of IgM antibodies to Epstein-Barr virus capsid antigen in human serum to aid in differentiating active or recent infection from past infection. Presumptive for acute or recent 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

• Gull Laboratories' EBV IgM ELISA test

Submission Summary (Full Text)

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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.<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 IgM |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |

### 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.

## 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 IgM<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 : | Recombinant p18 | Purified gp 125 |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:51 | 1:11 |
| Sample Incubation<br>Duration: | 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 Incubation<br>Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl<br>phosphate | p-Nitrophenyl<br>phosphate |

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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 LABS<br>EBV VCA<br>IgM | 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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.
- 2. For in vitro diagnostic use only.
- 3. 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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)