IMMUNODOT MONO-G TEST

K974226 · Genbio · LSE · Sep 22, 1998 · Microbiology

Device Facts

• Record ID: K974226
• Device Name: IMMUNODOT MONO-G TEST
• Applicant: Genbio
• Product Code: LSE · Microbiology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome. This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

Device Story

ImmunoDOT Mono G is an ELISA-based in vitro diagnostic kit. It detects IgG antibodies to EBV-VCA, EBV-EBNA, CMV, and toxoplasma in human serum samples. The device functions by identifying specific antibody-antigen reactions; results are visualized as dots on the test medium. The intensity of the dot correlates with the presence and level of the antibody. The test is intended for use in clinical laboratory environments by trained laboratory personnel. Healthcare providers use the qualitative results to assist in the serodiagnosis of infectious mononucleosis and related mononucleosis-like syndromes. The device provides diagnostic information to support clinical decision-making regarding patient infection status.

Clinical Evidence

Prospective clinical study conducted at two sites (Site A and Site B). Total sample size included hundreds of serum specimens. Primary endpoints were sensitivity and specificity for EBV infectious mononucleosis and mononucleosis syndrome compared to reference results. EBV sensitivity was 98.8% (96-99.7% CI) and specificity was 93% (93-99% CI). Mononucleosis syndrome sensitivity was 98.7% (96-99.7% CI) and specificity was 89% (77-96% CI). Precision testing showed 85-100% reproducibility across varying antibody levels.

Technological Characteristics

ELISA-based qualitative enzyme immunoassay. Utilizes dot-based detection of IgG antibodies. Form factor is a diagnostic test kit. No automated software or electronic connectivity described; manual visual interpretation of dot intensity.

Indications for Use

Indicated for qualitative detection of IgG antibodies to EBV-VCA, EBV-EBNA, CMV, and toxoplasma in serum. Used as an aid in serodiagnosis of infectious mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome. Not for blood/plasma donor screening, prenatal screening, newborn testing, or point-of-care 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

• ImmunoDOT Infectious Mononucleosis Test (GenBio)

Submission Summary (Full Text)

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K974226

# 510(k) Summarv

| Contact | Bryan Kiehl |
|-----------|------------------------------------------------------------|
| Address | GenBio<br>15222-A Avenue of Science<br>San Diego, CA 92128 |
| Telephone | [phone] ext 309 |
| FAX | [phone] |
| Email | [e-mail] |
| Date: | 17 September, 1998 |

| DEVICE NAME | IMMUNODOT MONO G TEST |
|---------------------------------------|-----------------------|
| Common, usual, or classification name | Mononucleosis Test |
| Classification Number (if known) | |

Identification of the legally marketed device substantial equivalence is claimed: ImmunoDOT Infectious Mononucleosis Test, GenBio, San Diego, CA

## Description of the new device:

The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.

## Intended Use of New Device:

The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.

This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

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## Similarities and/or differences

| ITEM | PREDICATE DEVICE | NEW DEVICE |
|-------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Methodology | ELISA | ELISA |
| Specimen Type | Serum | Serum |
| Test Objective | Mononucleosis Serology | Mononucleosis Serology |
| Product type, e.g.,<br>calibrator, control, kit | Kit | Kit |
| Intended Use | Mononucleosis Serodiagnosis | Mononucleosis Serodiagnosis |
| Other | EBV, CMV and toxoplasma<br>infections. IgG and IgM are<br>detected within one assay. | EBV, CMV and toxoplasma<br>infections. IgG and IgM are<br>detected separately but<br>reported together. |

## Relative Performance

A prospective study was performed to assess assay performance. Site A information based on profile comparison is presented in Table 1. Site B information is shown in Table 2 and the combined data can be seen in Table 3.

| | Reference Results | | |
|---------------|-------------------|---------|-------------|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 33 | 0 | 1 |
| Current | 2 | 23 | 1 |
| Past/Recent | 0 | 1 | 112 |
| Indeterminate | 0 | 6 | 7 |

### Table 1: Site A EBV Performance

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| | Reference Results | | |
|---------------|-------------------|---------|-------------|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 9 | 0 | 0 |
| Current | 1 | 10 | 1 |
| Past/Recent | 0 | 0 | 92 |
| Indeterminate | 2 | 0 | 1 |

#### Table 2: Site B EBV Performance

#### Table 3: EBV Performance Summary

| | Reference Results | | |
|---------------|-------------------|---------|-------------|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 42 | 0 | 1 |
| Current | 3 | 33 | 2 |
| Past/Recent | 0 | 1 | 204 |
| Indeterminate | 2 | 6 | 8 |

There was no toxoplasma IM cases identified during the prospective trial period. Two CMV mononucleosis cases at Site A and three CMV mononucleosis cases at Site B were observed. Three of the five sera from presumptive CMV mononucleosis cases were positive according to reference results. These CMV results are included in Table 4 as ImmunoDOT current positives and summarize overall ImmunoDOT performance.

| | Reference Results | | |
|---------------|-------------------|---------|-------------|
| ImmunoDOT | Negative | Current | Past/Recent |
| Negative | 42 | 0 | 1 |
| Current | 5 | 36 | 2 |
| Past/Recent | 0 | 1 | 199 |
| Indeterminate | 2 | 6 | 8 |

Table 4: Overall Performance Summary

Using the above information, assay performance characteristics are shown in Table 5. Indeterminate results are not used for the calculations.

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| | Sensitivity | Sensitivity<br>Range | Specificity | Specificity<br>Range |
|------------------------------|-----------------|----------------------|-------------|----------------------|
| EBV Infectious Mononucleosis | 98.8% (238/241) | 96-99.7% | 93% (42/45) | 93-99% |
| Mononucleosis Syndrome | 98.7% (236/239) | 96-99.7% | 89% (42/47) | 77-96% |

Table 5: Performance Characteristics

#### r a a

The intensity of the dot is directly related to precision. The darkest dots are most reliable while weaker reactions are proportionately less reliable. Site A and Site B laboratories were supplied masked specimens containing mixtures of the various analytes. Therefore, not all analytes tested the same number of replicates. Testing was conducted in triplicate each day. Tests were performed on six different days. The results are shown below. The results (Tables 12 and 13) show adequate qualitative discrimination for each analyte.

| Antibody Level | Level 1<br>Heterophil | Level 2<br>Heterophil | VCA IgM | CMV IgM |
|----------------|-----------------------|-----------------------|-----------------|-------------------|
| Moderate | 100%<br>(36/36) | 100%<br>(36/36) | 100%<br>(36/36) | 100%<br>(72/72) |
| Low | 100%<br>(108/108) | 100%<br>(108/108) | 100%<br>(72/72) | 100%<br>(144/144) |

Table 6: ImmunoDOT Mono M Precision Results

| Table 7: ImmunoDOT Mono G Precision Results | | | |
|---------------------------------------------|--|--|--|
|---------------------------------------------|--|--|--|

| Antibody Level | VCA IgG | EBNA IgG | CMV IgG | Toxoplasma IgG |
|----------------|-------------------|-------------------|-------------------|------------------|
| Moderate | 100%<br>(144/144) | 100%<br>(36/36) | 100%<br>(144/144) | 100%<br>(72/72) |
| Low | 100%<br>(72/72) | 100%<br>(144/144) | 100%<br>(72/72) | 85%<br>(122/144) |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bryan L. Kiehl, Ph.D. Vice President GenBio 15222 Avenue of Science, Suite A San Diego, California 92128

Re: K974226/S2 Trade Name: ImmunoDOT Mono-G Regulatory Class: I Product Code: LSE Dated: July 7, 1998 Received: July 8, 1998

Dear Dr. Kiehl:

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 Requlations, 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,.. J for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

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 leqally 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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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# Indications for Use

510(k) Number (if known):

Device Name: ImmunoDOT Mono-G

Indications for Use:

The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.

This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).

> (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

510(k) Nimber