ADVIA Centaur Herpes-1 IgG

K181333 · Biokit, S.A. · MXJ · Aug 23, 2018 · Microbiology

Device Facts

• Record ID: K181333
• Device Name: ADVIA Centaur Herpes-1 IgG
• Applicant: Biokit, S.A.
• Product Code: MXJ · Microbiology
• Decision Date: Aug 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Indications for Use

The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive 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, pediatic patients or matrices other than human serum and plasma (EDTA and lithium heparin).

Device Story

The ADVIA Centaur Herpes-1 IgG is a chemiluminescent immunoassay used for the qualitative detection of IgG antibodies to HSV-1 in human serum and plasma. It is designed for use on the ADVIA Centaur systems in clinical laboratory settings. The device processes patient samples to determine serological status, aiding clinicians in the diagnosis of HSV-1 infection. Results are provided as an index value, which clinicians use alongside patient history and prevalence data to inform diagnostic decisions. The assay provides a standardized, automated alternative to manual immunoblot methods, potentially improving laboratory efficiency and diagnostic consistency.

Clinical Evidence

Clinical study evaluated 864 specimens (including 274 pregnant women) across 3 sites. Performance compared to a commercial immunoblot and Western Blot reference. Overall sensitivity was 97.5% (95% CI: 95.8%-98.5%) and specificity was 96.2% (95% CI: 93.6%-97.8%). In the pregnant population, sensitivity was 98.7% (95% CI: 95.5%-99.7%) and specificity was 98.3% (95% CI: 94.0%-99.5%). Precision studies (CLSI EP05-A3) and interference testing (CLSI EP7-A2) were also performed.

Technological Characteristics

Chemiluminescent immunoassay for use on ADVIA Centaur systems. Analyzes human serum, EDTA plasma, and lithium heparin plasma. Reagents stable for 60 days onboard; calibration interval 28 days. Automated processing.

Indications for Use

Indicated for sexually active adults and expectant mothers to aid in the presumptive diagnosis of HSV-1 infection. Not for blood/plasma donor screening. Performance not established for immunocompromised or pediatric patients.

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

• Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2018

Biokit, S.A. Joan Guixer QA & RA Director Can Male S/N Llica d'Amunt, 08186 Barcelona, Spain

Re: K181333

Trade/Device Name: ADVIA Centaur Herpes-1 IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MXJ Dated: May 17, 2018 Received: May 25, 2018

Dear Joan Guixer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

#### Steven R. Gitterman -S for

Uwe Scherf, 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) k181333

Device Name ADVIA Centaur Herpes-1 IgG

#### Indications for Use (Describe)

The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive 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, pediatic patients or matrices other than human serum and plasma (EDTA and lithium heparin).

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

| 1. Submitter's Information | Biokit, S.A.<br>Can Malé S/N<br>Lliçà d'Amunt 08186<br>Barcelona (Spain) |
|----------------------------|--------------------------------------------------------------------------|
|----------------------------|--------------------------------------------------------------------------|

| 2. Contact Person | Joan Guixer, QA & RA Director<br>Phone: [phone]<br>Email: [e-mail] |
|-------------------|----------------------------------------------------------------------------------------------------------|
|-------------------|----------------------------------------------------------------------------------------------------------|

| 3. Preparation Date | May 17th, 2018 |
|---------------------|----------------|
|---------------------|----------------|

| 5. Regulatory<br>Information | Regulation Number | 21 CFR 866.3305 |
|------------------------------|------------------------|---------------------------------------------|
| | Regulation Description | Herpes simplex virus<br>serological assays. |
| | Classification | Class II Special Controls |
| | Product Code | MXJ |
| | Classification Panel | Microbiology |

| 6. Predicate Device | K000238 (Focus HerpeSelect 1 and 2 Immunoblot IgG) |
|---------------------|----------------------------------------------------|
|---------------------|----------------------------------------------------|

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| <b>7. Indications for Use /<br/>Intended Use</b> | The ADVIA Centaur Herpes-1 IgG (HSV1) assay is for <i>in vitro</i> diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. This assay is intended for use as an aid in the determination of serological status to HSV-1 and in the diagnosis of herpes simplex virus infection. |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| COMPARISON PREDICATE | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate | New Device |
| Trade Names | Focus HerpeSelect 1 and 2<br>Immunoblot IgG | ADVIA Centaur Herpes-1 IgG |
| 510K nº | K000238 | Pending |
| Manufacturer | Focus Diagnostic<br>Cypress, CA 90630 -USA | Siemens Heathcare<br>Diagnostics Inc.<br>511 Benedict Avenue,<br>Tarrytown, NY 10591- USA |
| Similarities | | |
| Intended use | Focus Diagnostics HerpeSelect 1<br>and 2 Immunoblot IgG test is | The ADVIA Centaur Herpes-1<br>IgG (HSV1) assay is for in vitro |
| | intended for qualitatively detecting<br>the presence or absence of human<br>IgG class antibodies to HSV-1 and<br>HSV-2 in human sera. The test is<br>indicated for testing sexually active<br>adults or expectant mothers for<br>aiding in the presumptive diagnosis<br>of HSV-1 and HSV-2 infection. The<br>predictive value of a positive or<br>negative result depends on the<br>population's prevalence and the<br>pretest likelihood of HSV- 1 and<br>HSV-2 infection. The performance<br>of this assay has not been<br>established for use in a pediatric<br>population, for neonatal screening,<br>for testing of<br>immunocompromised patients, for<br>use by a point of care facility or for<br>use with automated equipment | diagnostic use in the<br>qualitative determination of<br>IgG antibodies to herpes<br>simplex virus type 1 (HSV-1)<br>in human serum and plasma<br>(EDTA and lithium heparin)<br>using the ADVIA Centaur<br>systems. This assay is<br>intended for use as an aid in<br>the determination of<br>serological status to HSV-1<br>and in the diagnosis of<br>herpes simplex virus<br>infection. |
| Measurand | To detect the presence or absence<br>of human IgG class antibodies to<br>HSV-1 and HSV-2 | To detect IgG antibodies to<br>herpes simplex virus type 1<br>(HSV-1). |
| Regulation Section | 21 CFR 866.3305 | Same |
| Product Code | LGC | MXJ |
| Classification | Class II Special Controls | Same |
| Assay Type | Qualitative | Same |
| Differences | | |
| Technology | Nitrocellulose immunoblot | Chemiluminescent<br>immunoassay |
| Sample type | Human serum | Human serum and<br>plasma (EDTA and lithium<br>heparin) |

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## 9. Performance Summary

## Precision

A precision study was performed according to CLSI EP05-A3 using the Negative and Positive Controls as well as 6 samples prepared at different levels in the assay range. Each material was tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level.

The ADVIA Centaur HSV1 assay is designed to have the following repeatability and withinlab precision requirements:

| | Design Requirement | |
|----------------------------------|-----------------------|--------------------|
| ADVIA Centaur HSV1 Level (Index) | Repeatability<br>% CV | Within-Lab<br>% CV |
| < 0.5 | NAa | NA |
| 0.51–0.79 | ≤ 10.0% | ≤ 15.0% |
| 0.80–1.20 | ≤ 6.0% | ≤ 8.0% |
| 1.21-3.00 | ≤ 5.0% | ≤ 7.0% |
| 3.01-6.00 | ≤ 5.0% | ≤ 7.0% |
| > 6.00 | ≤ 5.0% | ≤ 10.0% |

೩ NA = not applicable

The results for this study are presented below.

| Specimen Type | N | Mean<br>(Index) | Repeatability | | Within-Lab | |
|------------------------------|----|-----------------|---------------|--------|------------|-------|
| | | | SD | CV (%) | SD | CV(%) |
| Negative Control<br>(Plasma) | 80 | 0.26 | 0.01 | NAa | 0.03 | NAa |
| Positive Control<br>(Plasma) | 80 | 2.98 | 0.10 | 3.2 | 0.18 | 6.1 |
| Serum 1 | 80 | 0.25 | 0.03 | NAa | 0.04 | NAa |
| Serum 2 | 80 | 0.57 | 0.03 | 4.8 | 0.03 | 5.9 |
| Serum 3 | 80 | 0.97 | 0.03 | 3.1 | 0.04 | 4.5 |
| Serum 4 | 80 | 1.61 | 0.05 | 3.1 | 0.09 | 5.3 |
| Serum 5 | 80 | 4.08 | 0.20 | 4.9 | 0.26 | 6.4 |
| Serum 6 | 80 | 13.37 | 0.53 | 4.0 | 1.04 | 7.7 |

### Precision results for the HSV-1 Assay

NA = Not applicable

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## Sample matrix

This study was performed on one ADVIA Centaur XP instrument, using 68 sets of matched samples of different matrixes (serum, serum separator tube (SST), EDTA plasma and lithium heparin plasma) from commercial sources

The samples were analyzed in duplicate in randomized order using one reagent lot.

- . Comparing Serum Separator Tube (y) vs Serum (x): (Deming regression) y = -0.01 + 0.99 x, r=0.996, sample range for both matrixes 0.10-19.15 Index Value and 0.10-19.59 Index Value respectively. Note – correlation coefficient is calculated using linear regression.
- . Comparing EDTA Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998, sample range for both matrixes 0.10-19.14 Index Value and 0.11-19.19 Index Value respectively. Note - correlation coefficient is calculated using linear regression.
- . Comparing Lithium Heparin Plasma(y) vs Serum (x): (Deming regression) y= -0.02 + 0.96 x, r=0.998, sample range for both matrixes 0.10-19.15 Index Value and 0.10-18.73 Index Value respectively. Note - correlation coefficient is calculated using linear regression.

The results supports that Serum Separator Tube is equivalent matrix to Serum, EDTA Plasma is equivalent matrix to Serum and Lithium Heparin Plasma is an equivalent matrix to Serum.

## Panels

The commercial sample panels, Seracare Diagnostics and ToRCH-mixed Zeptometrix, and CDC panel were analysed.

The Seracare Diagnostics panel included 25 characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 92% total agreement was observed with reference assay 1.

The ToRCH-mixed Zeptometrix panel included 24 characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 96% total agreement was observed with reference assay 1.

The CDC panel included 100 blind characterized HSV samples. All of the samples were evaluated with the ADVIA Centaur Herpes-1 IgG assay on ADVIA Centaur XP instrument and 100% total agreement was observed in concordance with the results provided by the CDC.

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## Interferences

Potential interference in the ADVIA Centaur HSV1 assay from the compounds listed below is designed to be ≤ 10%. Interfering substances at the levels indicated were tested as described in CLSI Document EP7-A2.

The testing was done in three levels of samples in the assay range (high negative, low positive and positive samples) with at least one reagent lot on ADVIA Centaur XP instrument.

Testing confirmed no interference (Demonstrate ≤ 10% change in results) for the ADVIA Centaur Herpes-1 IgG up to the following concentrations:

| Serum specimens that are... | Demonstrate ≤10% change in results up to... |
|-----------------------------|---------------------------------------------|
| Biotin | 3500 ng/mL |
| Hemoglobin | 500 mg/dL |
| Bilirubin complex | 40 mg/dL |
| Bilirubin free | 40 mg/dL |
| Hypoproteinemia | 3 g/dL |
| Hyperproteinemia | 12 g/dL |
| Lipemia | 1000 mg/dL |
| Cholesterol | 400 mg/dL |

## Cross-reactivity

The ADVIA Centaur HSV1 assay was evaluated for potential cross-reactivity with other viral antibodies, disease-state specimens, and other populations. The HSV-1 lgG status of each specimen was verified using the Comparative Assay. Repeat equivocal specimens on the Comparative Assay were sent to a reference laboratory for Western Blot testing. Total percent agreement for the following clinical categories was 95.8% (413/431). The following results were obtained:

### Cross Reactivity Study Performance Results

| | Number | ADVIA Centaur HSV1 | Comparative Assay | |
|--------------------------------------------------------|---------------|--------------------------------|-------------------------------|--|
| Clinical Category | tested | Reactive | Positive | |
| Antibody to hepatitis B surface antigen (Anti-<br>HBs) | 10 | 8 | 8 | |
| Anti-gliadin | 10 | 6 | 6 | |
| Anti-nuclear antibody (ANA) | 10 | 5 | 5 | |
| Clinical Category | Number tested | ADVIA Centaur HSV1<br>Reactive | Comparative Assay<br>Positive | |
| Candida albicans | 10 | 10 | 9 | |
| Chlamydia trachomatis | 10 | 6 | 7a | |
| Cytomegalovirus (CMV IgG) | 10 | 6 | 7b | |
| Elevated IgG | 10 | 8 | 8 | |
| Elevated IgM | 10 | 9 | 10a/c | |
| Epstein-Barr virus (EBV VCA IgG) | 10 | 9 | 9 | |
| Escherichia coli | 10 | 9 | 9 | |
| Flu vaccine recipients | 10 | 3 | 3 | |
| Gardnerella vaginalis | 10 | 7 | 7 | |
| Hepatitis C virus (HCV) | 25 | 19 | 21 | |
| Hepatitis B surface antigen (HBsAg) | 10 | 9 | 9 | |
| Herpes simplex virus type 2 (HSV-2) | 74 | 35 | 33a | |
| Heterophile antibodies | 10 | 1 | 1 | |
| Human anti-mouse antibody (HAMA) | 31 | 24 | 25a | |
| Human herpes virus 6 (HHV-6) | 10 | 6 | 5 | |
| Human herpes virus 8 (HHV-8) | 10 | 9 | 9 | |
| Human immunodeficiency virus (HIV) | 10 | 10 | 10 | |
| Human Papillomavirus (HPV) | 10 | 6 | 6a | |
| Multiple myeloma | 10 | 10 | 10 | |
| Neisseria gonorrhoeae | 25 | 17 | 16 | |
| Parvovirus B19 | 10 | 4 | 4 | |
| Rheumatoid Factor (RF) | 10 | 6 | 6 | |
| Rubella IgG | 10 | 7 | 7 | |
| Syphilis | 10 | 9 | 9a | |
| Systemic lupus erythematosus (SLE) | 26 | 17 | 17 | |
| Toxoplasma IgG | 10 | 10 | 10 | |
| Varicella zoster virus (VZV) | 10 | 5 | 6a | |
| Total Specimens | 431 | 290 | 292 | |

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A Werfen Company

ª One sample was confirmed positive by Western Blot

Ь One sample was confirmed positive by Comparative Assay

< Two samples were confirmed positive by Comparative Assay

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Image /page/10/Picture/0 description: The image shows the logo for Biokit, a Werfen Company. The logo consists of two blue chevron-like shapes stacked on top of each other, followed by the word "Biokit" in gray. Below the word "Biokit" is the text "A Werfen Company" in a smaller, gray font. The logo is simple and modern, with a focus on the company name and affiliation.

## Clinical study

A multisite clinical study to compare the reference with ADVIA Centaur Herpes-1 lgG was performed. Sensitivity and specificity were determined by comparing the performance of the ADVIA Centaur HSV1 assay to a commercially available anti-HSV-1 IgG immunoblot method (Comparative Assay) and a validated Western Blot reference confirmatory test (University of Washington, Seattle).A total of 864 specimens (≥ 18 years of age), including specimens from 274 pregnant women, were collected within the United States and tested at 3 independent external laboratories. Samples were analyzed in singlicate. Of these specimens, 520 were reactive, and 344 were nonreactive with the ADVIA Centaur HSV1 assay. The overall agreement was 97.0% (838/864) with a 95% confidence interval (CI) of 95.6%-97.9%.

Of the 864 specimens tested by the Comparative Assay, 22 were equivocal and further tested by the Western Blot test. After Western Blot testing, 19 of the specimens were resolved to be negative and 3 remained equivocal.

| Intended use population | | Comparative Assay.<br>Equivocal results have been resolved by Western Blot (WB) | | | |
|-------------------------|-------------|---------------------------------------------------------------------------------|----------|-----------|-------|
| | | Positive | Negative | Equivocal | Total |
| ADVIA Centaur HSV1 | Reactive | 507 | 13 | 0 | 520 |
| | Nonreactive | 10 | 331 | 3 | 344 |
| | Total | 517 | 344 | 3 | 864 |

The results obtained for the intended use population are presented below

The sensitivity of the ADVIA Centaur HSV1 assay was 97.5% (507/520), with a 95% confidence interval (CI) of 95.8%-98.5%.

The specificity of the ADVIA Centaur HSV1 assay was 96.2% (331/344), with a 95% confidence interval (CI) of 93.6%-97.8%.

Sensitivity and specificity were determined for the pregnant population by comparing the performance of the ADVIA Centaur HSV1 assay to the Comparative Assay and Western Blot confirmatory method.The results of the pregnant women samples are presented below:

| Pregnant women | Comparative Assay<br>Equivocal results have been resolved by Western Blot (WB) | | | | |
|--------------------|--------------------------------------------------------------------------------|-----|-----|---|-----|
| ADVIA Centaur HSV1 | Reactive | 155 | 2 | 0 | 157 |
| | Nonreactive | 2 | 115 | 0 | 117 |
| | Total | 157 | 117 | 0 | 274 |

### Pregnant women Study Contingency (WB resolution) table

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## A Werfen Company

The sensitivity of the ADVIA Centaur HSV1 assay was 98.7% (155/157) with a 95% confidence interval of 95.5%-99.7%.

The specificity of the ADVIA Centaur HSV1 assay was 98.3% (115/117) with a 95% confidence interval of 94.0%-99.5%.

#### 10. Stability

The onboard stability of the ADVIA Centaur Herpes-1 IgG reagents is 60 days with a calibration interval of 28 days. The onboard stability of the ADVIA Centaur Herpes-1 IgG Calibrators is 8 hours. The opened vial stability of the ADVIA Centaur Herpes-1 IgG Calibrators is 65 days. Unopened reagents and calibrators are stable until the date printed on the box label when stored at 2-8°C.

#### 11. Conclusion

The analytical and clinical study results demonstrate that the ADVIA Centaur Herpes-1 IgG are substantially equivalent to the predicate device, Focus HerpeSelect 1 and 2 Immunoblot IgG (FDA cleared under K000238), and that the assay is safe and effective for its labeled intended use.