BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

K161816 · bioMerieux, Inc. · MDB · Mar 28, 2017 · Microbiology

Device Facts

• Record ID: K161816
• Device Name: BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
• Applicant: bioMerieux, Inc.
• Product Code: MDB · Microbiology
• Decision Date: Mar 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Indications for Use

BacT/ALERT® VIRTUO™ Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.

Device Story

BacT/ALERT VIRTUO is an automated blood culture system for clinical laboratories. It incubates, agitates, and monitors culture bottles (SA, SN, FA Plus, FN Plus, PF Plus) for microbial growth. The system uses a robotic arm for automated loading/unloading of bottles from a conveyor. Operation involves colorimetric sensing: CO2 production from microbial metabolism changes a gas-permeable sensor from blue-green to yellow; this increases light reflectance, which is monitored by an LED/photodiode optical system. Reflectance data is processed by proprietary firmware/software algorithms to detect growth. The system features a tactile graphical interface and internal network access. By automating bottle handling and continuous monitoring, it provides rapid detection of microorganisms, aiding clinicians in diagnosing bloodstream infections and guiding antimicrobial therapy.

Clinical Evidence

Clinical evaluation conducted at eight sites comparing VIRTUO to BacT/ALERT 3D using 5,862 bottle pairs (blood and sterile body fluids). Primary endpoints included microbial recovery and detection rates. Results showed equivalent performance: false positive rates were 0.09% (VIRTUO) vs 0.19% (3D); false negative rates were 0.38% (VIRTUO) vs 0.38% (3D). Control testing (n=2,976) showed 99.9% accuracy. Data confirms VIRTUO provides equivalent detection of aerobic, facultative, and anaerobic organisms.

Technological Characteristics

Automated microbial growth monitor. Features: electrically heated forced air convection incubator; 12.5° horizontal sinusoidal rocking (50-60 cycles/min); robotic arm for automated loading. Detection: colorimetric sensor (CO2-sensitive) with 634nm LED emitter and photodiode detector. Connectivity: internal customer network access. Software: proprietary detection algorithms embedded in firmware/software. Capacity: 108-6912 bottles.

Indications for Use

Indicated for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids in patients suspected of having bacteremia, fungemia, or other microbial infections.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• BacT/ALERT® 3D Microbial Detection System (K903505/A2)

Submission Summary (Full Text)

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

March 28, 2017

BIOMERIEUX, INC. JOLYN TENLLADO DIRECTOR GLOBAL REGULATORY AFFAIRS MICROBIOLOGY 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K161816

Trade/Device Name: BacT/ALERT® VIRTUO™ Microbial Detection System Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: I Product Code: MDB Dated: February 21, 2017 Received: February 23, 2017

Dear Ms. Tenllado:

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,

# Ribhi Shawar -A

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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#### 1.5 - Indications for Use (FDA FORM 3881)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) Unknown at time of 510(k) Submission

Device Name BacT/ALERT® VIRTUO(TM) Microbial Detection System

Indications for Use (Describe)

BacT/ALERT® VIRTUO(TM) Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic microorganism growth from blood and other normally sterile body fluids.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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B.

C.

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## 510(k) SUMMARY

## BacT/ALERT® VIRTUO™ Microbial Detection System

### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|--------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>Director, Global Regulatory Affairs Microbiology |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 30, 2016 |
| Device Name: | |
| Formal/Trade Name: | BacT/ALERT® VIRTUO™ Microbial Detection<br>System |
| Classification Name: | 21 CFR 866.2560, Microbial Growth Monitor |
| Common Name: | BacT/ALERT® VIRTUO™; VIRTUO™ |
| Predicate Device: | BacT/ALERT® 3D Microbial Detection System<br>(K903505/A2) |

#### D. 510(k) Summary:

#### Intended Use:

BacT/ALERT® VIRTUO™ Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.

#### Device Description:

The VIRTUO Instrument is the next generation of the bioMerieux BacT/ALERT Microbial Detection System. This blood culture instrument consists of an incubator, agitation mechanism, robotic apparatus for automated loading and unloading of bottles and a tactile graphical interface. The VIRTUO is used in conjunction with existing, commercialized BacT/ALERT reagent bottles for clinical use (BacT/ALERT SA, SN, FA Plus, FN Plus and PF Plus culture bottles).

#### Page 001 - 1.10-1

#### bioMérieux, Inc. Phone: [phone] Anglum Road, Hazelwood, Missouri 63042-2320, USA Fax: [phone]

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The VIRTUO system utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the inoculated sample, carbon dioxide is produced as the organisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The color change results in an increase of reflectance units monitored by the system. The VIRTUO optically monitors the reflectance of each bottle over time and will store and interpret readings against algorithms, which are embedded in the firmware and/or software.

| | New Device:<br>BacT/ALERT VIRTUO | Predicate Device:<br>BacT/ALERT 3D |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The BacT/ALERT® VIRTUOTM<br>Microbial Detection System is<br>an automated microbial test<br>system capable of incubating,<br>agitating, and continuously<br>monitoring for the detection of<br>aerobic, facultative, and<br>anaerobic microorganism<br>growth from blood and other<br>normally sterile body fluids.<br><br>Note: The intial release of the<br>system will not include detection<br>of Mycobacterium species<br>growth from clinical specimens. | The BacT/ALERT® 3D Microbial<br>Detection System is a totally<br>automated test system capable<br>of incubating, agitating, and<br>continuously monitoring aerobic<br>and anaerobic media inoculated<br>with patient specimens<br>suspected of having bacteremia,<br>fungemia, and/or<br>mycobacteremia (Clinical Use) |
| Reagent | For use with the BacT/ALERT<br>SA, SN, FA Plus, PF Plus and<br>FN Plus culture bottles (Clinical<br>Use) | For use with the BacT/ALERT<br>SA, SN, FA, PF, FN, MP, FA<br>Plus, FN Plus, PF Plus (Clinical<br>Use) |
| Detection Method<br>for Microbial<br>Growth | Reflectance change of<br>colorimetric sensor over time to<br>measure metabolic reactants | Reflectance change of<br>colorimetric sensor over time to<br>measure metabolic reactants |
| Incubation &<br>Agitation | Electrically heated forced air<br>convection incubation.<br>Continuous 12.5° from<br>horizontal sinusoidal rocking of<br>reagent & sample @50-60<br>cycles/minute. | Electrically heated forced air<br>convection incubation.<br>Continuous 12.5° from<br>horizontal sinusoidal rocking of<br>reagent & sample @50-60<br>cycles/minute. |
| Colorimetric<br>Optics | LED emitter with 634nm peak<br>wavelength and 17nm<br>bandwidth/photodiode detector.<br>Four point graduated grey scale<br>optical calibration. | LED emitter with 634nm peak<br>wavelength and 17nm<br>bandwidth/photodiode detector.<br>Four point graduated grey scale<br>optical calibration. |
| Differences | | |
| Detection<br>algorithms | Proprietary algorithms unique<br>for BacT/ALERT VIRTUO | Proprietary algorithms unique<br>for BacT/ALERT 3D |
| Capacity | 108-6912 bottles | 240-1440 bottles |
| Bottle Loading | Automated loading of bottles<br>placed on conveyor (up to 40 at<br>a time) with bottle label<br>scanning, measuring of sample | Customer scans bottle labels<br>and loads the bottle into a bottle<br>cell of an open drawer, one<br>bottle at a time |

| Table 1: Similarities & Differences Between BacT/ALERT Microbial Detection Systems | |
|------------------------------------------------------------------------------------|--|
|------------------------------------------------------------------------------------|--|

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#### Section 1.10

| | volume & loading via robotic<br>arm into open incubator cell with<br>appropriate agitation. Customer<br>can manually load bottles if<br>automation features are not<br>operable | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Remote<br>Customer Access | Internal (customer site) network<br>access | Unavailable |

#### Performance Characteristics:

The BacT/ALERT VIRTUO Microbial Detection System demonstrated substantially equivalent performance when compared with the BacT/ALERT 3D Microbial Detection System. This 510(k) Premarket Notification presents data in support of the BacT/ALERT VIRTUO. External performance evaluations were conducted at eight external clinical sites. The evaluation included testing of blood & sterile body fluids using the BacT/ALERT SA, SN, FA Plus, PF Plus and FN Plus culture bottles with the VIRTUO and 3D Systems.

The following tables compare results of the BacT/ALERT VIRTUO to BacT/ALERT 3D blood cultures for all compliant blood culture bottles that yielded any number of isolates on subculture.

| Clinical Determination | VIRTUO True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|--------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 64 | 6.1 (64/1057) | 66 | 6.2 (66/1057) | 0.970 | 0.821,<br>1.119 |
| Contaminant | 7 | 0.7 (7/1057) | 11 | 1.0 (11/1057) | 0.636 | |
| Unknown | 2 | 0.2 (2/1057) | 2 | 0.2 (2/1057) | 1.000 | |
| Total | 73 | 6.9 (73/1057) | 79 | 7.5 (79/1057) | 0.924 | 0.766,<br>1.082 |

| BacT/ALERT FA Plus: Blood - Compliant -- Single and Multiple Isolates |
|-----------------------------------------------------------------------|
|-----------------------------------------------------------------------|

#### BacT/ALERT FN Plus: Blood - Compliant - Single and Multiple Isolates

| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D<br>True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of<br>True<br>Positives | 95% CI<br>(LCL,<br>UCL) |
|------------------------|-----------------------------|------------------------------------------------|----------------------------|-----------------------------------------------|-------------------------------|-------------------------|
| Significant | 47 | 5.2 (47/912) | 48 | 5.3 (48/912) | 0.979 | 0.823,<br>1.135 |
| Contaminant | 13 | 1.4 (13/912) | 10 | 1.1 (10/912) | 1.300 | |
| Unknown | 0 | 0.0 (0/912) | 0 | 0.0 (0/912) | - | |
| Total | 60 | 6.6 (60/912) | 58 | 6.4 (58/912) | 1.034 | 0.852,<br>1.216 |

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| | | | BacT/ALERT PF Plus: Blood - Compliant - Single and Multiple Isolates |
|--|--|--|----------------------------------------------------------------------|
| | | | |

| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 1 | 0.6 (1/161) | 1 | 0.6 (1/161) | 1.000 | -1.772,<br>3.772* |
| Contaminant | 0 | 0.0 (0/161) | 0 | 0.0 (0/161) | - | |
| Unknown | 0 | 0.0 (0/161) | 0 | 0.0 (0/161) | - | |
| Total | 1 | 0.6 (1/161) | 1 | 0.6 (1/161) | 1.000 | -1.772,<br>3.772* |

*Since the confidence interval contains a negative, the interval does not pe interval does not provide a meaningful interpretation.

#### Low Fill BacT/ALERT FA Plus: Blood – Compliant – Single and Multiple Isolates

| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL,<br>UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|-------------------------|
| Significant | 28 | 7.4 (28/379) | 29 | 7.7 (29/379) | 0.966 | 0.790,<br>1.142 |
| Contaminant | 4 | 1.1 (4/379) | 3 | 0.8 (3/379) | 1.333 | |
| Unknown | 1 | 0.3 (1/379) | 0 | 0.0 (0/379) | - | |
| Total | 33 | 8.7 (33/379) | 32 | 8.4 (32/379) | 1.031 | 0.790,<br>1.272 |

#### BacT/ALERT SA: Blood Culture – Compliant – Single and Multiple Isolates

| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 40 | 5.1 (40/780) | 39 | 5.0 (39/780) | 1.026 | 0.857,<br>1.195 |
| Contaminant | 4 | 0.5 (4/780) | 10 | 1.3 (10/780) | 0.400 | |
| Unknown | 2 | 0.3 (2/780) | 1 | 0.1 (1/780) | 2.000 | |
| Total | 46 | 5.9 (46/780) | 50 | 6.4 (50/780) | 0.920 | 0.736,<br>1.104 |

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| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 32 | 3.9 (32/830) | 30 | 3.6 (30/830) | 1.067 | 0.797,<br>1.337 |
| Contaminant | 1 | 0.1 (1/830) | 4 | 0.5 (4/830) | 0.250 | |
| Unknown | 1 | 0.1 (1/830) | 0 | 0.0 (0/830) | - | |
| Total | 34 | 4.1 (34/830) | 34 | 4.1 (34/830) | 1.000 | 0.730,<br>1.270 |

#### BacT/ALERT SN: Blood – Compliant – Single and Multiple Isolates

The following tables compare results of the BacT/ALERT VIRTUO to BacT/ALERT 3D sterile body fluid cultures that yielded single or multiple isolates on subculture.

| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Significant | 42 | 11.2 (42/374) | 42 | 11.2 (42/374) | 1.000 | 0.852,<br>1.148 |
| Contaminant | 8 | 2.1 (8/374) | 6 | 1.6 (6/374) | 1.333 | |
| Unknown | 5 | 1.3 (5/374) | 4 | 1.1 (4/374) | 1.250 | |
| Total | 55 | 14.7 (55/374) | 52 | 13.9 (52/374) | 1.058 | 0.864,<br>1.252 |

#### BacT/ALERT FA Plus: SBF - Single and Multiple Isolates

#### BacT/ALERT FN Plus: SBF - Single and Multiple Isolates

| | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL, UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|----------------------|
| Clinical Determination | | | | | | |
| Significant | 39 | 8.9 (39/437) | 38 | 8.7 (38/437) | 1.026 | 0.838,<br>1.214 |
| Contaminant | 9 | 2.1 (9/437) | 8 | 1.8 (8/437) | 1.125 | |
| Unknown | 4 | 0.9 (4/437) | 6 | 1.4 (6/437) | 0.667 | |
| Total | 52 | 11.9 (52/437) | 52 | 11.9 (52/437) | 1.000 | 0.794,<br>1.206 |

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| Clinical Determination | VIRTUO<br>True<br>Positives | % of VIRTUO True<br>Positives in<br>Population | BTA3D True<br>Positives | % of BTA3D True<br>Positives in<br>Population | Ratio of True<br>Positives | 95% CI<br>(LCL,<br>UCL) |
|------------------------|-----------------------------|------------------------------------------------|-------------------------|-----------------------------------------------|----------------------------|-------------------------|
| Significant | 14 | 18.2 (14/77) | 15 | 19.5 (15/77) | 0.933 | 0.807,<br>1.059 |
| Contaminant | 0 | 0.0 (0/77) | 2 | 2.6 (2/77) | 0.000 | |
| Unknown | 1 | 1.3 (1/77) | 0 | 0.0 (0/77) | - | |
| Total | 15 | 19.5 (15/77) | 17 | 22.1 (17/77) | 0.882 | 0.665,<br>1.099 |

## BacT/ALERT SA: Sterile Body Fluids - Single and Multiple Isolates

#### BacT/ALERT SN: Sterile Body Fluids - Single and Multiple Isolates

| Clinical Determination | VIRTUO True Positives | % of VIRTUO True Positives in Population | BTA3D True Positives | % of BTA3D True Positives in Population | Ratio of True Positives | 95% CI (LCL, UCL) |
|------------------------|-----------------------|------------------------------------------|----------------------|-----------------------------------------|-------------------------|-------------------|
| Significant | 17 | 21.0 (17/81) | 17 | 21.0 (17/81) | 1.000 | 0.837,<br>1.163 |
| Contaminant | 1 | 1.2 (1/81) | 1 | 1.2 (1/81) | 1.000 | |
| Unknown | 1 | 1.2 (1/81) | 0 | 0.0 (0/81) | - | |
| Total | 19 | 23.5 (19/81) | 18 | 22.2 (18/81) | 1.056 | 0.806,<br>1.306 |

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#### Section 1.10

When all 5862 bottle pairs tested are considered, false positive rates were 0.09% (5/5862) and 0.19% (11/5862) for VIRTUO and BTA3D, respectively. False negative rates were 0.38% (22/5862) and 0.38% (22/5862) for VIRTUO and BTA3D, respectively, While the algorithm on VIRTUO is new and has some differences compared to that of the BTA3D, these results for VIRTUO and BTA3D demonstrate an equivalent ability of the two systems to detect and recover organisms in BacT/ALERT bottles and demonstrate the efficacy of the VIRTUO Detection algorithm. The yields of microorganisms are similar between VIRTUO and BTA3D.

There were 1490 positive controls tested on VIRTUO for all sites combined. Of those, 1487 (99.8%) were signaled positive by VIRTUO. There were 1486 negative controls tested for all sites combined. Of those, 1486 (100%) were signaled negative by VIRTUO. Of the total of 2976 controls tested over the course of the clinical trial, VIRTUO gave the expected result for 2973/2976 (99.9%) of the controls.

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