SeraQuest Herpes Type 1 Specific IgG

K162276 · Quest International, Inc. · MXJ · Oct 1, 2016 · Microbiology

Device Facts

• Record ID: K162276
• Device Name: SeraQuest Herpes Type 1 Specific IgG
• Applicant: Quest International, Inc.
• Product Code: MXJ · Microbiology
• Decision Date: Oct 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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 1 Specific IgG is an ELISA for qualitative detection of human IgG antibodies to HSV-1 in human serum. Device uses recombinant HSV gG-1 antigen coated on polystyrene microwells. Patient samples are diluted and incubated in wells; if HSV-1 IgG is present, it binds to the antigen. After washing, enzyme-labeled goat anti-human IgG conjugate is added; if IgG is bound, conjugate is immobilized. Substrate (p-nitrophenyl phosphate) is added, converting to a yellow end-product measured photometrically. Results are reported as Index values (<=0.9 negative, 0.9-1.0 equivocal, >=1.0 positive). Used in clinical laboratories by trained personnel. Output aids clinicians in presumptive diagnosis of HSV-1 infection by identifying previous immunologic exposure. Does not determine active infection or disease stage.

Clinical Evidence

Clinical performance evaluated in 164 sexually active adults and 242 expectant mothers compared to a commercial HSV-1 immunoblot. In adults, sensitivity was 92.3% (95% CI: 85.0-96.2) and specificity was 91.7% (95% CI: 83.2-96.2). In expectant mothers, sensitivity was 93.3% (95% CI: 87.3-96.6) and specificity was 89.4% (95% CI: 87.1-93.7). Additional validation performed using a 100-sample CDC serum panel.

Technological Characteristics

Solid-phase ELISA using recombinant HSV gG-1 antigen on polystyrene microwells. Employs alkaline phosphatase-conjugated goat anti-human IgG and p-nitrophenyl phosphate substrate. Readout is spectrophotometric. Requires three 30-minute incubations at room temperature. Manual or automated processing (though performance not established for automated equipment).

Indications for Use

Indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. Not for use in immunocompromised patients, pediatric patients, or for screening blood/plasma donors.

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).

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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a symbolic representation of an eagle above them.

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

October 1, 2016

QUEST INTERNATIONAL, INC DAVID J. KIEFER, PH.D. DIRECTOR RESEARCH AND DEVELOPMENT 8127 NW 29TH STREET MIAMI FL 33122

Re: K162276

Trade/Device Name: SeraQuest HSV Type 1 Specific IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: II Product Code: MXJ Dated: August 10, 2016 Received: August 12, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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" (21 CFR 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) K162276

Device Name

SeraQuest® HSV Type 1 Specific IgG

#### Indications for Use (Describe)

For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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.

| 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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### 510(k) Summary

| 510(k) Number: | k162276 |
|-------------------------|----------------------------------------------------------------------|
| Purpose for Submission: | New Device |
| Type of Test: | Enzyme linked immunosorbent assay (ELISA) |
| Measurand: | IgG Antibody to Herpes Simplex Virus-1 (HSV-1) |
| Applicant: | Quest International, Inc.<br>8127 NW 29th Street<br>Doral, FL. 33122 |
| Contact Person: | David J. Kiefer, Ph.D. |
| Telephone: | 305 592-6991 |
| Telefax: | 305 592-6834 |
| Device: | SeraQuest® HSV Type 1 Specific IgG |

#### Requlatory Information:

- 1. Regulation section: Herpes simplex virus serological assays 21 CFR§866.3305
- 2. Classification: Class II
- 3. Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, HSV-1)
- 4. Panel: Microbiology (83)

#### Cataloque Number: 01-410

#### Intended Use:

For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzymelinked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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.

#### Description:

The SeraQuest® HSV Type 1 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty minute

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incubations. The test detects IqG antibodies which are directed against HSV 1 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 1 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-1 IgG antibodies detected. Patient is presumed not to have had a previous HSV-1 infection. |
| 0.9 < X < 1.0 | Equivocal | Obtain an additional sample for re-testing |
| $\geq$ 1.0 | Positive | IgG antibody to HSV-1 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 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-1 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 1 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-1 are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the substrate is added and incubated. In the presence of the conjugate, the substrate is converted to a yellow end-product which is read photometrically.

Substantial Equivalence Information:

- 1. Predicate device name(s): Focus HerpeSelect® 1 and 2 Immunoblot IgG
- 2. Predicate 510(k) number(s): K000238

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#### 3. Comparison with predicate:

| | Table 1. Comparison with the Predicate | | |
|--|----------------------------------------|--|--|
|--|----------------------------------------|--|--|

| Similarities | | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| ltem | SeraQuest HSV 1 IgG | Focus HerpeSelect 1 and 2<br>Immunoblot IgG (Predicate) | |
| Intended Use | For In Vitro<br>Diagnostic Use Only. The<br>SeraQuest HSV Type 1<br>Specific IgG assay is an<br>enzyme-linked immunosorbent<br>assay (ELISA) intended for the<br>qualitative detection of human<br>lgG antibodies to type 1<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-1 infection. The<br>predictive value of a positive or<br>negative result depends on the<br>prevalence of HSV-1 infection<br>in the population and<br>the pre-test likelihood of HSV-<br>1 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. | Focus Diagnostics'<br>HerpeSelect 1 and 2<br>Immunoblot IgG test is<br>intended for qualitatively<br>detecting the presence or<br>absence of human IgG class<br>antibodies to HSV-1 and<br>HSV-2 in human sera. The<br>test is indicated for testing<br>sexually active adults or<br>expectant mothers for aiding<br>in the presumptive diagnosis<br>of HSV-1 and HSV-2<br>infection. The predictive value<br>of a positive or negative result<br>depends on the population's<br>prevalence and the pretest<br>likelihood of HSV-1 and HSV-<br>2 infection.<br>The performance of this<br>assay has not been<br>established for use in a<br>pediatric population, for<br>neonatal screening, for<br>testing of<br>immunocompromised<br>patients, for use by a point of<br>care facility or for use with<br>automated equipment. | |
| Sample Matrix | Human Serum | Human Serum | |
| Antigen | Recombinant HSV gG 1 | Recombinant HSV gG 1 | |
| Incubation Periods | Three | Three | |
| Incubation Temperature | Room Temperature | Room Temperature | |
| Enzyme-Labeled Conjugate | Alkaline phosphatase<br>conjugated goat anti-human<br>IgG | Alkaline phosphatase<br>conjugated goat anti-human<br>IgG | |
| Controls | Positive and negative controls<br>included with kit | Positive and negative controls<br>included with kit | |
| Differences | | | |
| Type of Assay | Enzyme linked immunoassay<br>(ELISA) | Nitrocellulose immunoblot | |
| Solid Phase | Polystyrene Microwells | Nitrocellulose membrane | |
| Calibrator | Included with reagent kit | Not included | |
| Sample Dilution | 1:51 | 1:101 | |
| Sample Volume | 100 uL | 2000 uL | |
| Sample incubation duration | 30 minutes | 60 minutes | |
| Washing Steps | Two | Four | |
| Cycles per wash step | Four | Three | |
| Conjugate Volume | 100 uL | 2000 uL | |
| Enzyme substrate | p-nitrophenyl phosphate | Bromo-chloro-indolyl<br>phosphate and nitro blue<br>tetrazolium | |
| Substrate Volume | 100 uL | 200 uL | |
| Substrate Incubation | 30 minutes | 5 to 30 minutes | |
| Stop Reagent | 0.5 M Trisodium Phosphate | De-ionized Water | |
| Stop Reagent Volume | 100 uL | 5X2000 uL | |
| Drying Step | None | Air dry, 10 minutes | |
| Readout | Spectrophotometric | Visual | |
| Unit of Measure | Index value | Positive or negative | |

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## Summary of Performance Testing

### 1. Precision Testing

Six serum specimens (2 negative, 1 equivocal and 3 positive) and the SeraQuest HSV Type 1 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-<br>laboratory | | Total | |
|-------------------------------------|-------------|---------------|-------------|------|-------------|------|----------------------|------|-------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| SeraQuest Positive<br>Serum Control | 27 | 2.0 | 0.12 | 5.8 | 0.13 | 7.2 | 0.17 | 8.5 | 0.14 | 7.2 |
| SeraQuest Negative<br>Serum Control | 27 | 0.3 | 0.03 | 10.1 | 0.08 | 23.7 | 0.12 | 39.0 | 0.08 | 24.2 |
| Negative Sample # 1 | 27 | 0.3 | 0.02 | 7.0 | 0.03 | 10.7 | 0.12 | 43.0 | 0.05 | 20.1 |
| Negative Sample # 2 | 27 | 0.5 | 0.01 | 2.6 | 0.03 | 5.6 | 0.09 | 17.7 | 0.04 | 8.7 |
| Equivocal Sample | 27 | 1.0 | 0.08 | 8.6 | 0.10 | 10.7 | 0.15 | 15.1 | 0.11 | 11.4 |
| Positive Sample # 1 | 27 | 1.8 | 0.12 | 6.7 | 0.16 | 8.9 | 0.23 | 12.7 | 0.17 | 9.5 |
| Positive Sample # 2 | 27 | 1.9 | 0.11 | 5.8 | 0.18 | 9.5 | 0.21 | 11.2 | 0.17 | 8.8 |
| Positive Sample # 3 | 27 | 2.6 | 0.11 | 4.3 | 0.20 | 7.6 | 0.43 | 16.6 | 0.25 | 9.5 |

### 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 1 HSV antibody by another legally marketed device. Only those samples that tested negative for Type 1 HSV antibody by the legally marketed device were included in the study. The results of this study are shown below in Table 3.

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Table 3. Results of SeraQuest HSV Type 1 Specific IgG Tests of Samples Which Tested Positive for Antibodies Directed Against Taxonomically Related Viruses and Other Viruses and Pathogens but Negative for Type 1 HSV by Other Legally Marketed Devices.

| Samples | Number of Samples | Number of Samples Testing Positive in the<br>SeraQuest HSV 1 Type Specific IgG Test |
|-----------------------|-------------------|-------------------------------------------------------------------------------------|
| HSV 2 IgG | 10 | 0/10 |
| CMV IgG | 11 | 0/11 |
| EBV EBNA IgG | 13 | 0/13 |
| EBV VCA IgG | 17 | 0/17 |
| VZV IgG | 19 | 0/19 |
| Measles IgG | 20 | 0/20 |
| Rubella IgG | 15 | 0/15 |
| Toxoplasma IgG | 6 | 0/6 |
| Syphilis IgG | 4 | 0/4 |
| Human Papilloma | 2 | 1/2 |
| Chlamydia trachomitis | 1 | 0/1 |
| Neisseria gonorrhea | 3 | 1/3 |

### 3. Interference Testing

The effects of icterus, hemolysis, hyperglycemia, hyperlipidemia and hyperproteinemia on the test results were examined. Samples that were negative, weakly positive and moderately positive for antibodies to Type 1 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 using the SeraQuest HSV Type 1 Specific IgG test and a commercial HSV 1 Immunoblot test. The results of this comparative test are shown in Table 4 below.

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#### Table 4.

#### Relative Sensitivity and Specificity of the SeraQuest HSV 1 Type Specific IgG Test in Comparison with an HSV 1 Immunoblot Test for 164 Sexually Active Adults Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

| SeraQuest HSV 1 Type Specific IgG Result | | | | | |
|------------------------------------------|----------|-----------|----------|------------------|--------------|
| HSV 1 Immunoblot Result | Positive | Equivocal | Negative | % Agreement* | 95% C.I.* |
| Positive | 84 | 1 | 6 | Sensitivity 92.3 | 85.0 to 96.2 |
| Negative | 3 | 3 | 67 | Specificity 91.7 | 83.2 to 96.2 |

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 using the SeraQuest HSV Type 1 Specific IgG test and a legally marketed, HSV 1 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 1 Type Specific IqG Test in Comparison with a Commercial HSV 1 Immunoblot Test for 242 Expectant Mothers Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

| Seraquest HSV 1 Type Specific IgG Result | | | | % Agreement* | | | 95% C.I.* |
|------------------------------------------|----------|-----------|----------|--------------|------|--|--------------|
| HSV 1 Immunoblot<br>Result | Positive | Equivocal | Negative | | | | |
| Positive | 111 | 3 | 5 | Sensitivity | 93.3 | | 87.3 to 96.6 |
| Negative | 13 | 0 | 110 | Specificity | 89.4 | | 87.1 to 93.7 |

### 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 1 Specific IgG test. The results are presented as a means to convey further information on the performance of this assay with a masked, well characterized serum panel. This does not

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imply an endorsement by the CDC.

#### Percent Agreement with the CDC Panel

The panel consists of 46 HSV-1 IgG positive and 54 HSV-1 IgG negative samples. The results of this study are shown below in Table 7.

#### Table 6. SeraQuest HSV Type 1 Specific IgG Results Obtained with the CDC HSV Panel of 100 Sera

| | | SeraQuest HSV Type 1 Specific IgG | | | |
|------------------|----------|-----------------------------------|-----------|----------|-------|
| | | Positive | Equivocal | Negative | Total |
| CDC HSV 1 Result | Positive | 42 | 2 | 2 | 46 |
| | Negative | 0 | 1 | 53 | 54 |
| | Total | 42 | 3 | 55 | 100 |

#### Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.