VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
K103209 · Nanosphere, Inc. · OCC · Jan 10, 2011 · Microbiology
Device Facts
Record ID
K103209
Device Name
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
Applicant
Nanosphere, Inc.
Product Code
OCC · Microbiology
Decision Date
Jan 10, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3980
Device Class
Class 2
Attributes
Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K103209 · Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
Nanosphere, Inc.
Residual nasopharyngeal swab specimens from symptomatic patients
Residual clinical specimens collected during routine respiratory seasons were used to establish the performance characteristics (sensitivity/specificity) of the Verigene RV+ test compared to culture/DFA and sequencing.
RV+ Methods Comparison Study; Prospective collection of residual clinical specimens; Follow-up/Duration: 2008-2009 and 2009-2010 respiratory seasons; Study Period: 2008-2010
Symptomatic patients presenting with respiratory tract infection; Sample Size: 1022; Number of Sites: 3
Culture-based methods confirmed with FDA-cleared DFA test; bidirectional sequencing for subtyping
Sensitivity and specificity for detection of Influenza A, Influenza B, and RSV (and subtypes)
Indications for Use
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Device Story
The Verigene System is a bench-top molecular diagnostics workstation comprising a Processor SP and a Reader. It processes nasopharyngeal swab specimens to detect respiratory viral nucleic acids. The workflow involves automated magnetic bead-based viral RNA extraction, multiplex RT-PCR amplification, and gold nanoparticle probe-based hybridization. The Processor SP performs fluid transfer and mixing via a robotic pipettor. The Reader manages test ordering, controls the Processor SP, performs automated imaging of the test cartridge, and generates results. The system is used in clinical laboratory settings by trained personnel. The output provides qualitative identification of specific viral targets, aiding clinicians in diagnosing respiratory infections. The device benefits patients by providing rapid, multiplexed viral identification to inform clinical management.
Clinical Evidence
Clinical methods comparison study of 1022 prospective nasopharyngeal specimens across three sites. RV+ results compared to culture/DFA and bidirectional sequencing. Influenza A sensitivity 98.7%, specificity 93.2%. Influenza B sensitivity 100%, specificity 99.7%. RSV sensitivity 97.2%, specificity 99.5%. Subtype-specific sensitivities were 100% for H3, H1, 2009 H1N1, RSV A, and RSV B. Reproducibility/precision study showed agreement ranging from 97.2% to 100% across sites.
Technological Characteristics
Bench-top molecular workstation (Processor SP and Reader). Uses silica-coated magnetic beads for extraction, multiplex RT-PCR for amplification, and gold nanoparticle probe-based hybridization for detection. Single-use disposable test cartridges with microfluidic channels. Connectivity: Reader controls up to 32 Processor units. Software: Embedded application on Micro-C/OS real-time operating system.
Indications for Use
Indicated for qualitative detection and identification of Influenza A (H1, H3, 2009 H1N1), Influenza B, and RSV (A, B) nucleic acids in nasopharyngeal swab specimens from symptomatic patients. Not for Influenza C detection. Results intended as an aid in diagnosis alongside clinical/laboratory findings; not for sole diagnostic or treatment decisions.
Regulatory Classification
Identification
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.
Special Controls
*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
Predicate Devices
Verigene® Respiratory Virus Nucleic Acid Test (RVNATSP) (K092566)
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K103209
Image /page/0/Picture/1 description: The image contains the word "Nanosphere" in a bold, sans-serif font. To the left of the word is a circular logo that is partially filled with diagonal lines. The logo is black and white, and the text is black.
JAN 1 0 2011
## 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
"
| 510(k)<br>numbers: | K103209: Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene® System (RV+) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary<br>preparation<br>date: | December 28, 2010 |
| Submitted<br>by: | Nanosphere, Inc.<br>4088 Commercial Avenue<br>Northbrook, IL 60062<br>Phone: 847-400-9000 Fax: 847-400-9199 |
| Contact: | Gregory W. Shipp, M.D.<br>Chief Medical Officer<br>VP, Medical and Regulatory Affairs |
| Proprietary<br>names: | For instrument:<br>Verigene® System<br>For the assay:<br>Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene® System (RV+) |
| Common<br>names: | For the instrument:<br>Bench-top molecular diagnostics workstation<br>For the assay:<br>Respiratory viral panel multiplex nucleic acid assay<br>Respiratory panel assay with sub-typing:<br>- Flu A (H3, H1, 2009H1N1)<br>- Flu B<br>- RSV (RSV A, RSV B) |
| Regulatory<br>information: | Regulation section:<br>866.3980 Respiratory viral panel multiplex nucleic acid assay<br>Class II<br>Panel:<br>Microbiology (83)<br>Product Code:<br>OCC (Respiratory viral panel multiplex nucleic acid assay) |
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| Comparison<br>of RVNATSP<br>and RV+: | The instrumentation used with the RVNATSP (K092566) and the RV+ is identical. The Verigene® System<br>utilized for both assays allows sample preparation, target amplification, and hybridization test and analysis<br>using a single system. The RVNATSP and the RV+ reagents and substrate have been modified to allow<br>subtyping of Influenza A (H3, H1, 2009H1N1) and RSV (RSV A, RSV B). The safety and effectiveness of the<br>Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene System (RV+) are demonstrated with the<br>analytical and methods comparison studies described below. | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The RV+ is designed to identify virus-specific nucleic acids for Influenza A virus, Influenza A virus subtype H1,<br>Influenza A virus subtype H3, Influenza A virus subtype 2009 H1N1, Influenza B virus, and respiratory syncytial<br>virus (RSV A. RSV B). The RVNATSP involves: | |
| | 1) Sample Preparation - magnetic bead-based viral RNA extraction from nasopharyngeal swab specimens<br>obtained from symptomatic patients; | |
| | 2) Target Amplification - multiplex RT-PCR-based amplification of the eluted viral RNA targets to generate<br>virus-specific amplicons; | |
| | 3) Verigene Hybridization Test and Analysis - detection and identification of virus-specific amplicons by using<br>gold nanoparticle probe-based technology. | |
| The entire RV+ test is performed on the Verigene® System, which is a bench-top molecular diagnostics<br>workstation that consists of two instruments, the Verigene Processor SP and the Verigene Reader. The<br>Verigene Processor SP performs the assay steps on each sample by using a robotic pipettor to transfer and<br>mix reagents within and between separate testing modules designed for nucleic acid extraction, target<br>amplification, and the Verigene Hybridization Test. The Verigene Hybridization Test module is the same as in<br>the original Verigene System with added modules for nucleic acid extraction and RT-PCR target amplification.<br>Key functions of the Verigene Processor SP include: | | |
| | 1) Reading of the barcode identification label on inserted Test Consumables to maintain positive identification<br>of patient samples throughout processing. | |
| | 2) Facilitation of nucleic acid extraction, multiplex RT-PCR target amplification, and the Verigene<br>Hybridization Test. | |
| Device<br>description: | 3) Real-time communication of test processing status to the Reader. | |
| | The Verigene Reader is the same instrument as in the FDA-cleared RVNATSP. It is a free-standing instrument<br>with a touch screen control panel and a wand-based barcode scanner. It utilizes a graphical user interface to<br>guide the user through the process of ordering tests and reporting results. There are no serviceable parts and<br>no user calibration is required. Interaction with the touch screen is minimized through barcode use. This<br>instrument also serves as the reader of the Test Cartridges using advanced optics. The key functions of the<br>Verigene Reader include: | |
| | 1) Entry and tracking of specimen identification numbers via manual keyboard input or via barcode-reader<br>wand. | |
| | 2) Test selection for each specimen. | |
| | 3) Automated transfer of specimen processing instructions on Test Cartridge-specific basis to linked<br>Processor SP unit(s). A single Reader unit can control up to 32 Processor units. | |
| | 4) Automated imaging and analysis of Test Cartridges. | |
| | 5) Results display. | |
| | 6) Results report generation. | |
| | RV+ consumables within each single-use disposable test kit include: (i) Tip Holder Assembly; (ii) Extraction<br>Tray; (iii) Amplification Tray; and (iv) RV+ Test Cartridge. The kit components are inserted into the<br>corresponding module of the Verigene Processor SP prior to each test, and the sample is added to the<br>Extraction Tray. Patient information is entered into the Reader to initiate the test procedure. | |
| | 1) Tip Holder Assembly - The robotic pipettor picks up pipettes from the Tip Holder Assembly. The pipettes<br>are used for mixing and transferring reagents within the test procedure. | |
| Intended<br>use: | 2) Extraction Tray – Nucleic acids are extracted from the sample by using magnetic bead-based methods<br>within the Extraction Tray. Each Tray contains reagents for a single extraction procedure. A robotic pipette<br>transfers reagents to designated wells within the Extraction Tray to affect the steps of lysis, capture of<br>nucleic acids onto the magnetic beads, washing, and eluting the isolated nucleic acids from the magnetic<br>beads. | |
| | 3) | Amplification Tray – The isolated nucleic acids are amplified by using multiplex RT-PCR within the<br>Amplification Tray. Each Tray contains reagents for a single multiplex RT-PCR procedure. A robotic<br>pipette transfers the reagents to a specific well within the Amplification Tray. A set thermal profile is then<br>initiated to perform all of the amplification related steps including UDG-based decontamination, reverse<br>transcription, and multiplex PCR in a single tube. Upon completion, an aliquot of the amplified sample is<br>mixed with hybridization buffer containing the virus specific mediator probes. The sample is then<br>transferred to the Test Cartridge. |
| | 4) | RV+ Test Cartridge for Verigene Hybridization Test – The virus-specific and subtype-specific amplicons are<br>detected and identified within a Test Cartridge by using specific nucleic acid probes in conjunction with gold<br>nanoparticle probe-based detection technology. Each Test Cartridge is a self-contained, laboratory<br>consumable that consists of two parts. The upper housing of each cartridge is called the "reagent pack"<br>and contains reservoirs filled with the detection reagents. When in place with the 'substrate holder', the<br>reagent pack creates an air-tight hybridization chamber surrounding the region of the substrate containing<br>a target-specific capture array. As each step of the test is completed, old reagents are moved out of the<br>hybridization chamber and new reagents are added from the reagent pack via microfluidic channels and<br>pumps. Once the test is complete, the Test Cartridge is removed from the Verigene Processor SP unit and<br>the reagent pack is snapped off and discarded. The remaining slide is now ready for imaging and analysis<br>in the Verigene Reader. |
| | 5) | End-point detection on the Verigene Reader: The test slide is inserted into the Verigene Reader wherein it<br>is illuminated along its side. The gold-silver aggregates at the test sites scatter the light, which is in turn<br>captured by a photosensor. The relative intensity arising from each arrayed test site is tabulated. Net<br>signals, defined as the absolute signal intensities with background signals subtracted, are compared with<br>thresholds determined by negative controls within the slide in order to arrive at a decision regarding the<br>presence or absence of target. These results are linked to the test and patient information entered at the<br>beginning of each test session to provide a comprehensive results file. |
| | The Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene® System (RV+) is a qualitative nucleic acid<br>multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP)<br>swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and<br>subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza<br>B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus.<br>Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection<br>aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. | |
| | Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be<br>used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-<br>out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The<br>use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of<br>respiratory viral infection. | |
| | Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the<br>predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. | |
| | If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria<br>recommended by public health authorities, specimens should be collected with appropriate infection control precautions<br>used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture<br>should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. | |
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### Comparison between the Cleared and the New Systems
| Feature | Verigene RV+ | Verigene RVNAT SP | Prodesse ProFAST+ | Specimen | Nasopharyngeal swabs in sample matrix | Nasopharyngeal swabs in sample matrix | Nasopharyngeal swabs in sample matrix |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------…
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