SeraQuest HSV Type 2 Specific IgG

K152353 · Quest International, Inc. · MYF · May 13, 2016 · Microbiology

Device Facts

• Record ID: K152353
• Device Name: SeraQuest HSV Type 2 Specific IgG
• Applicant: Quest International, Inc.
• Product Code: MYF · Microbiology
• Decision Date: May 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

Device Story

SeraQuest HSV Type 2 Specific IgG is a solid-phase ELISA for qualitative detection of human IgG antibodies to HSV-2 in human serum. Input: human serum sample. Process: sample incubated in recombinant HSV gG2 antigen-coated polystyrene microwells; immobilized IgG antibodies bind antigen; alkaline phosphatase-conjugated goat anti-human IgG added; substrate (p-nitrophenyl phosphate) converted to yellow product. Output: spectrophotometric index value. Used in clinical laboratories; performed by laboratory technicians. Results aid in presumptive diagnosis of HSV-2 infection; positive result indicates previous immunologic exposure. Does not determine active infection or disease stage.

Clinical Evidence

Clinical performance evaluated via prospective, masked, archived testing of 164 sexually active adults and 242 expectant mothers compared to a commercial HSV-2 Immunoblot. In sexually active adults, sensitivity was 91.8% (95% CI: 82.2-96.5) and specificity was 94.2% (95% CI: 87.9-97.3). In expectant mothers, sensitivity was 98.9% (95% CI: 93.8-99.8) and specificity was 99.4% (95% CI: 96.4-99.9). Additional validation using a 100-sample CDC serum panel showed 100% agreement with consensus results.

Technological Characteristics

Solid-phase ELISA; polystyrene microwell solid phase; recombinant HSV gG2 antigen; alkaline phosphatase-conjugated goat anti-human IgG; p-nitrophenyl phosphate substrate; spectrophotometric readout; manual/automated incubation at room temperature; index value output.

Indications for Use

Indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. Not for use in immunocompromised patients, pediatric patients, or blood/plasma donor screening.

Regulatory Classification

Identification

Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).

Predicate Devices

• HSV 1 and 2 Immunoblot IgG

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2016

Quest International, Inc. Dr. David J. Kiefer, Ph.D. Director, Research and Development 8127 NW 29th Street Miami, FL 33122

Re: K152353

Trade/Device Name: SeraQuest HSV Type 2 Specific IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: April 14, 2016 Received: April 14, 2016

Dear Dr. Kiefer:

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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Stephen J. Lovell -S for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152353

Device Name SeraOuest HSV Type 2 Specific IgG

#### Indications for Use (Describe)

1. Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

2. For In Vitro Diagnostic Use Only.

3. A positive result indicates previous exposure to Type 2 Herpes Simplex Virus.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 5. 510k Summary

### 510(k) Summary

| Applicant: | Quest International, Inc.<br>8127 NW 29th Street<br>Doral, FL. 33122 |
|------------------------|----------------------------------------------------------------------|
| Registration No. | 1061839 |
| Contact Person: | David J. Kiefer, Ph.D. |
| Telephone: | 305 592-6991 |
| Telefax: | 305 592-6834 |
| Device: | SeraQuest® HSV Type 2 Specific IgG |
| Medical Device Group: | In vitro diagnostic |
| Device Classification: | Class 2 |

Catalogue Number: 01-420

#### Description:

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values. The following table shows the interpretation of results:

| Index | Result | Interpretation |
|---------------|-----------|------------------------------------------------------------------------------------------------------|
| $\leq$ 0.9 | Negative | No HSV-2 IgG antibodies detected. Patient is presumed not to<br>have had a previous HSV-2 infection. |
| 0.9 < X < 1.0 | Equivocal | Obtain an additional sample for re-testing |
| $\geq$ 1.0 | Positive | IgG antibody to HSV-2 detected. |

Notes:

- 1. A single positive result only indicates previous immunologic exposure; the level of antibody response may not be used to determine active infection or disease stage.
- 2. When equivocal results are obtained, another specimen should be obtained ten to fourteen days later, and tested in parallel with the initial specimen. If the second specimen is also

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equivocal, the patient is negative for primary or recent infection, and equivocal for antibody status. If the second sample is positive, the patient can be considered to have previous experience with HSV-2 infection.

- 3. Values obtained with different manufacturer's assay methods may not be used interchangeably. The magnitude of the reported IgG index value cannot be correlated to an endpoint titer. The magnitude of results above the cut-off is not an indicator of total antibody present.
#### Principle:

Diluted patient samples are incubated in antigen-coated wells. HSV Type 2 antibodies, if present in the patient sample, are immobilized in the wells by binding to the antigen. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV-2 are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the substrate is added and incubated. In the presence of the substrate is converted to a yellow end-product which is read photometrically.

#### Intended Use:

Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

#### Predicate Device:

A commercial, legally marketed HSV 1 and 2 Immunoblot IgG test.

| Characteristic | SeraQuest HSV 2 IgG | HSV 1 and 2 Immunoblot IgG |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Technology | Enzyme Immunoassay | Immunoblot |
| Intended Use | Intended Use: For In Vitro<br>Diagnostic Use Only. The<br>SeraQuest HSV Type 2<br>Specific IgG assay is an | For In Vitro Diagnostic Use.<br>For qualitatively detecting the<br>presence or absence of<br>human IgG class antibodies to |
| | | |
| | enzyme-linked<br>immunosorbent assay<br>(ELISA) intended for the<br>qualitative detection of human<br>lgG antibodies to type 2<br>herpes simplex virus (HSV) in<br>human serum. The test is<br>indicated for sexually active<br>individuals and expectant<br>mothers as an aid in the<br>presumptive diagnosis of<br>HSV-2 infection. The<br>predictive value of a positive<br>or negative result depends on<br>the prevalence of HSV-2<br>infection in the population and<br>the pre-test likelihood of HSV-<br>2 infection.<br>The test is not FDA cleared<br>for screening blood or plasma<br>donors. The performance of<br>this assay has not been<br>established for<br>immunocompromised<br>patients, pediatric patients or<br>matrices other than human<br>serum. | HSV-1 and HSV-2 in human<br>sera. The test is indicated for<br>testing sexually active adults<br>or expectant mothers for<br>aiding in the presumptive<br>diagnosis of HSV-1 and HSV-<br>2 infection. The predictive<br>value of a positive or negative<br>result depends on the<br>population's prevalence and<br>the pre-test likelihood of HSV-<br>1 or HSV-2 infection. The<br>performance of this assay has<br>not been established for use<br>in a pediatric population, for<br>neonatal screening, for testing<br>immuno-compromised<br>patients, for use by a point of<br>care facility, or for use with<br>automated equipment. |
| Solid Phase | Polystyrene Microwells | Nitrocellulose membrane |
| Antigen | Purified HSV gG 2 | Recombinant HSV gG1 and<br>HSV gG2 |
| Incubation Periods | Three | Three |
| Sample Dilution | 1:51 | 1:101 |
| Sample Volume | 100 µL | 2000 µL |
| Sample Incubation Duration | 30 minutes | 60 minutes |
| Incubation Temperature | Room Temperature | Room Temperature |
| Washing Steps | Two | Four |
| Cycles per Washing Step | Four | Three |
| Enzyme-Labeled Conjugate | Alkaline Phosphatase<br>Conjugated Goat Anti-Human<br>lgG | Alkaline Phosphatase<br>Conjugated Goat Anti-Human<br>lgG |
| | | |
| Conjugate Volume | 100 μL | 2000 μL |
| Conjugate Incubation | 30 minutes | 30 minutes |
| Enzyme Substrate | p-nitrophenyl phosphate | Bromo-chloro-indolyl<br>phosphate and nitro blue<br>tetrazolium |
| Substrate Volume | 100 μL | 2000 μL |
| Substrate Incubation | 30 minutes | 5 to 30 minutes |
| Stop Reagent | 0.5 M Trisodium Phosphate | DI Water |
| Stop Reagent Volume | 100 μL | 5 X 2000 μL |
| Drying Step | None | Air dry, 10 minutes |
| Readout | Spectrophotometric<br>405 nm | Visual |

#### Table 1. Device Comparison

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#### Summary of Performance Testing

#### 1. Precision Testing

Six serum specimens (2 negative) and 4 positive) and the SeraQuest HSV Type 2 Specific IgG Positive and Negative Controls, were assayed in triplicate, on three separate occasions, at Quest International and at two external independent laboratories. The results are summarized below in Table 2.

#### Table 2.

Results of Intra-assay, Inter-assay and Inter-laboratory Precision Tests Performed at Quest International and at Two External, Independent Laboratories. The Means, Standard Deviations and Coefficients of Variation were Calculated from the SeraQuest Index values.

| Name of Analyte<br>Panel Member | Sample<br>N | Mean<br>Index | Intra-assay | | Inter-assay | | Inter-laboratory | | Total | |
|-------------------------------------|-------------|---------------|-------------|------|-------------|------|------------------|------|-------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| SeraQuest Positive<br>Serum Control | 27 | 2.0 | 0.20 | 9.9 | 0.27 | 13.7 | 0.31 | 15.4 | 0.26 | 13.0 |
| SeraQuest Negative<br>Serum Control | 27 | 0.3 | 0.04 | 13.5 | 0.08 | 21.2 | 0.15 | 48.2 | 0.09 | 27.6 |
| Negative Sample # 1 | 27 | 0.3 | 0.08 | 26.7 | 0.10 | 31.2 | 0.11 | 35.9 | 0.10 | 31.3 |
| Negative Sample # 2 | 27 | 0.4 | 0.04 | 9.6 | 0.06 | 14.4 | 0.09 | 21.6 | 0.06 | 15.2 |
| Positive Sample # 1 | 27 | 1.8 | 0.15 | 8.3 | 0.19 | 10.7 | 0.23 | 12.4 | 0.19 | 10.5 |
| Positive Sample # 2 | 27 | 2.1 | 0.12 | 5.7 | 0.18 | 8.8 | 0.21 | 10.0 | 0.17 | 8.1 |
| Positive Sample # 3 | 27 | 2.8 | 0.16 | 5.6 | 0.25 | 9.0 | 0.32 | 11.4 | 0.24 | 8.7 |
| Positive Sample # 4 | 27 | 3.5 | 0.27 | 7.8 | 0.38 | 10.7 | 0.42 | 11.9 | 0.36 | 10.1 |

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# 2. Specificity Testing

A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with the test results. The samples were determined to be positive for IgG antibodies directed against taxonomically related viruses and other related pathogens by other legally marketed devices. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections. The samples were also tested for Type 2 HSV antibody by another legally marketed device. Only those samples that tested negative for Type 2 HSV antibody by the legally marketed device were included in the study. The results of this study are shown below in Table 3.

#### Table 3. Results of SeraQuest HSV Type 2 Specific IgG Tests of Samples Which Tested Positive for Antibodies Directed Against Taxonomically Related Viruses and Other Viruses and Pathogens but Negative for Type 2 HSV by Other Legally Marketed Devices.

| Samples | Number of Samples | Number of Samples Testing Positive in the<br>SeraQuest HSV 2 Type Specific IgG Test |
|-----------------------|-------------------|-------------------------------------------------------------------------------------|
| HSV 1 IgG | 9 | 0/9 |
| CMV IgG | 11 | 0/11 |
| VZV EBNA IgG | 14 | 0/14 |
| VZV VCA IgG | 17 | 0/17 |
| VZV IgG | 21 | 0/21 |
| Measles IgG | 19 | 0/19 |
| Rubella IgG | 18 | 0/18 |
| Toxoplasma IgG | 6 | 0/6 |
| Syphilis IgG | 4 | 0/4 |
| Human Papilloma Virus | 7 | 0/7 |
| Chlamydia trachomitis | 8 | 1/8 |
| Neisseria gonorrhea | 7 | 0/7 |

# 3. Interference Testing

The effects of icterus, hemolysis, hyperdicidemia and hyperproteinemia on the test results were examined. Samples that were negative, weakly positive and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of the following potential interfering substances: hemoglobin 18 g/dL, glucose 800 mg dL. cholesterol 2,720 mg/dL, globulin 28 g/dL, unconjugated bilirubin 20 mg/dL, conjugated bilirubin 20 mg/dL, human albumin 12 g/dL and ascorbic acid 3mg/dL.

No significant interference was observed in the presence of abnormally elevated levels of the potentially interfering substances tested, however the use of grossly hemolyzed, icteric or lipemic samples, as well as samples containing particulate matter or exhibiting obvious microbial contamination is not recommended and they should not be tested.

# 4. Comparison With The Predicate Device

One hundred and sixty-four serum samples, from sexually active adults that were submitted for HSV serology to a clinical laboratory in the Southeastern United States, were prospectively collected, masked, archived, and tested at Quest International, Inc. using the SeraQuest HSV

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Type 2 Specific IgG test and a commercial HSV 2 Immunoblot test. The results of this comparative test are shown in Table 4 below.

#### Table 4

#### Relative Sensitivity and Specificity of the SeraQuest HSV 2 Type Specific IgG Test, in Comparison with an HSV 2 Immunoblot Test, in Parallel Tests of 164 Sexually Active Adults Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

| SeraQuest HSV 2 Type Specific IgG Result | | | | | | |
|------------------------------------------|----------|-----------|----------|-------------|--------------|--------------|
| | Positive | Equivocal | Negative | | % Agreement* | 95% C.I.* |
| HSV 2 Immunoblot<br>Result | | | | | | |
| Positive | 56 | 0 | 5 | Sensitivity | 91.8 | 82.2 to 96.5 |
| Negative | 6 | 0 | 97 | Specificity | 94.2 | 87.9 to 97.3 |

Two hundred and forty-two serum samples, from expectant mothers, that were submitted for HSV serology to clinical laboratories in the Northeastern and Southeastern United States, were prospectively collected, masked, archived, and tested at Quest International, Inc. using the SeraQuest HSV Type 2 Specific IgG test and a legally marketed, HSV 2 Immunoblot test. One hundred and ninety-eight (82%) of the specimens were obtained during the first trimester, nineteen (8%) during the second trimester and twenty-five (10%) during the third trimester of pregnancy. The results of this comparative test are shown in Table 5 below.

#### Table 5

Sensitivity and Specificity of the SeraQuest HSV 2 Type Specific IgG Test, in Comparison with a Commercial HSV 2 Immunoblot Test, in Parallel Tests of 242 Expectant Mothers Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

| Seraquest HSV 2 Type Specific IgG Result | | | | | |
|------------------------------------------|----------|-----------|----------|------------------|--------------|
| HSV 2 Immunoblot Result | Positive | Equivocal | Negative | % Agreement* | 95% C.I.* |
| Positive | 87 | 0 | 1 | Sensitivity 98.9 | 93.8 to 99.8 |
| Negative | 0 | 1 | 153 | Specificity 99.4 | 96.4 to 99.9 |

# CDC Panel Results

The following information was obtained with the Centers for Disease Control and Prevention (CDC) serum panel for HSV serology assays, which was tested in-house by the SeraQuest HSV Type 2 Specific IgG test. The results are presented as a means to convey further information on

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the performance of this assay with a masked, well characterized serum panel. This does not imply an endorsement by the CDC.

#### Percent Agreement with the CDC Panel

The panel consists of 30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples. The SeraQuest HSV Type 2 Specific IgG test demonstrated 100% total agreement with the CDC consensus results. The results of this study are shown below in Table 7.

#### Table 7 SeraQuest HSV Type 2 Specific IgG Results Obtained with the CDC HSV Panel of 100 Sera

| | | SeraQuest HSV Type 2 Specific IgG | | | |
|------------------|----------|-----------------------------------|-----------|----------|-------|
| | | Positive | Equivocal | Negative | Total |
| CDC HSV 2 Result | Positive | 30 | 0 | 0 | 30 |
| | Negative | 0 | 0 | 70 | 70 |
| | Total | 30 | 0 | 70 | 100 |