Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)

K151226 · Cepheid · OCC · Dec 3, 2015 · Microbiology

Device Facts

• Record ID: K151226
• Device Name: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
• Applicant: Cepheid
• Product Code: OCC · Microbiology
• Decision Date: Dec 3, 2015
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The Cepheid Xpert® Flu+RSV Xpress Assay, performed on the GeneXpert® Xpress System, is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu+RSV Xpress Assay uses nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu+RSV Xpress Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus or respiratory syncytial virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2014-2015 influenza season. When other novel influenza A viruses are emerging, performance characteristics may vary. 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 for novel virulent influenza viruses and sent to state or local health departments 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 Xpert Flu+RSV Xpress Assay is an automated, multiplex real-time RT-PCR test for qualitative detection of influenza A, influenza B, and RSV. It uses nasopharyngeal swab specimens collected in the Xpert Nasopharyngeal Sample Collection Kit. The assay is performed on the GeneXpert Xpress System (GX-I), which integrates sample extraction, purification, amplification, and detection within a single-use, multi-chambered fluidic cartridge. The system uses an ultrasonic horn for cell lysis and an I-CORE thermocycler for real-time PCR. The process is hands-off and takes approximately 60 minutes. Results are automatically generated for clinician review. The device is intended for use in clinical settings, including by operators without clinical laboratory experience in CLIA-waived environments. It aids in diagnosis by providing rapid viral detection, allowing for timely clinical decision-making and patient management.

Clinical Evidence

Clinical performance was evaluated at 12 U.S. institutions during the 2014-2015 season using 2,435 NP swab specimens (2,176 fresh, 259 archived). Compared to an FDA-cleared molecular comparator, the assay demonstrated high PPA and NPA for Flu A, Flu B, and RSV. For fresh specimens, PPA/NPA were: Flu A (100%/94.8%), Flu B (100%/99.5%), and RSV (96.9%/99.6%). Reproducibility was assessed across three sites, three operators, and ten days, showing consistent performance. Initial invalid rate was 5.0%.

Technological Characteristics

Automated, multiplex real-time RT-PCR assay. Uses single-use, multi-chambered fluidic cartridges with integrated sample preparation (ultrasonic lysis) and I-CORE thermocycler. Includes Sample Processing Control (SPC) and Probe Check Control (PCC). Specimen collection via NP swab in transport medium (Hank's Balanced Salt Solution, BSA, L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, antibiotics/antifungals). System is the GeneXpert Xpress (GX-I).

Indications for Use

Indicated for patients with signs and symptoms of respiratory infection to aid in the diagnosis of influenza A, influenza B, and respiratory syncytial virus (RSV) infections. Uses nasopharyngeal swab specimens.

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

• Cepheid Xpert Flu/RSV XC (K142045)
• Cepheid Nasopharyngeal Sample Collection Kit (K042970)

Reference Devices

• ProFlu+ Assay

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 stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

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

Cepheid Scott Campbell, PhD, MBA Executive Director, Clinical Affairs 904 Caribbean Drive Sunnyvale, CA 94089

December 3, 2015

Re: K151226

Trade/Device Name: Xpert® Flu+RSV Xpress, Xpert® Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC, OOI, JSM Dated: May 5, 2015 Received: May 8, 2015

Dear Dr. Campbell:

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 (OS) 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/ResourcesforYou/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,

Uwe Scherf -S

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) K151226

#### Device Name Xpert Flu+RSV Xpress

Xpert® Nasopharyngeal Sample Collection Kit

#### Indications for Use (Describe)

The Cepheid Xpert Flu-RSV Xpress Assay, performed on the GeneXpert Xpress System, is an automated, multiplex realtime, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu+RSV Xpress Assay uses nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu+RSV Xpress Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude influenza virus or respiratory syncytial virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2014-2015 influenza season. When other novel influenza A viruses are emerging, performance characteristics may vary.

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 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.

The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens and to preserve and transport nasal aspirate/wash specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu Assay or the Xpert Flu/RSV XC Assay. The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu+RSV Xpress Assay.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 5.0 510(k) Summary

As required by 21 CFR Section 807.92(c).

| Submitted by: | Cepheid<br>904 Caribbean Drive<br>Sunnyvale, CA 90489<br>Phone number: [phone]<br>Fax number: [phone] |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott A. Campbell, PhD, MBA |
| Date of Preparation: | May 5, 2015 |
| Device: | |
| Trade name: | Xpert® Flu+RSV Xpress |
| Common name: | Xpert Flu+RSV Xpress Assay |
| Type of Test: | Automated, multiplex real-time reverse transcription-<br>polymerase chain reaction (RT-PCR) assay intended for the <i>in vitro</i> qualitative detection and differentiation of influenza A,<br>influenza B, and respiratory syncytial virus. |
| Regulation number/<br>Classification name/ | 866.3980/Respiratory viral panel multiplex nucleic acid assay/<br>866.2570/Instrumentation for clinical multiplex test systems<br>866.2390/Transport culture medium |
| Product code(s): | OCC, OOI, JSM |
| Classification | Class II |
| Advisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Devices<br>Name(s): | 1) For the detection and differentiation of influenza A,<br>influenza B, and RSV viral RNA in nasopharyngeal swab<br>specimens:<br>Cepheid Xpert Flu/RSV XC [510(k) #K142045]; and,<br><br>2) For the Sample Collection Kits: |

Cepheid Xpert Nasopharyngeal Sample Collection Kit [510(k) #K142045]

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## Device Description:

The Xpert Flu+RSV Xpress Assay is an automated in vitro diagnostic test for qualitative detection and differentiation of influenza A. influenza B, and respiratory syncytial virus (RSV). The assay is performed on the Cepheid GeneXpert Xpress System (GeneXpert Dx System, GX-I). The GeneXpert Xpress System platform automates and integrates sample extraction, purification, amplification, and detection of the target sequence in simple or complex samples using real-time PCR and reverse transcriptase PCR (RT-PCR) assays. The systems require the use of single-use disposable cartridges (the Xpert Flu+RSV Xpress cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The Xpert Flu+RSV Xpress Assay includes reagents for the detection and differentiation of influenza A, influenza B, and RSV viral RNA directly from nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge. The SPC is present to control for adequate processing of the target viruses and to monitor the presence of inhibitors in the PCR reaction. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.

The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time RT-PCR for detection and differentiation of influenza B and RSV viral RNA in approximately 60 minutes. The GeneXpert Xpress System, comprised of the GeneXpert Dx System GX-I, has one module that is capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing realtime PCR and RT-PCR and detection.

Specimens are collected following the instructions for collecting NP swab specimens provided in Xpert Flu+RSV Xpress Assay package insert for influenza and RSV testing. The Cepheid Xpert Nasopharyngeal Sample Collection Kit (Cepheid catalog #SWAB/B-100) is required but not provided for use with the assay. The NP swab specimen is placed in the Xpert viral transport medium and sent to the GeneXpert® Xpress testing area for processing. When stored in the transport medium, the NP swab specimen is stable for up to 24 hours at 2-30 °C or up to seven days at 2-8 °C. When ready to test the specimen, the user briefly mixes the specimen by inverting the tube five times, transfers the eluted material to the sample chamber in the top of the disposable fluidic cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert Xpress instrument platform, which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of RNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

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## Device Intended Use:

Xpert Flu+RSV Xpress Assay:

The Cepheid Xpert® Flu+RSV Xpress Assay, performed on the GeneXpert® Xpress System, is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu+RSV Xpress Assay uses nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu+RSV Xpress Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude influenza virus or respiratory syncytial virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2014-2015 influenza season. When other novel influenza A viruses are emerging, performance characteristics may vary.

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 for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Ancillary Collection Kits' Indications for Use (the expanded indication is shown in bold):

## Xpert Nasopharyngeal Sample Collection Kit

The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens and to preserve and transport nasal aspirate/wash specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu Assay or the Xpert Flu/RSV XC Assay. The Xpert® Nasopharyngeal Sample Collection Kit is designed to collect, preserve, and transport nasopharyngeal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Flu+RSV Xpress Assay.

## Substantial Equivalence:

The Xpert Flu+RSV Xpress Assay is substantially equivalent to the Cepheid Xpert Flu/RSV XC Assay [510(k) #K142045]. The Xpert Flu+RSV Xpress Assay and the Xpert Flu/RSV XC Assay detect influenza A. influenza B. and RSV from NP swab specimens. Both assays utilize the same technology by determining the presence of the target organisms through realtime RT-PCR amplification and fluorogenic target-specific hybridization detection. A multi

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center clinical study was conducted to determine the performance characteristics of the device with collection of NP swab specimens from each subject relative to a comparator device, the ProFlu+ Assay which is FDA cleared for NP swab specimens. Discordant results between the Xpert Flu+RSV Xpress Assay and the ProFlu+ Assay were analyzed by sequencing using primers different from those used in the Xpert Flu-RSV Xpress Assay. The study results showed the Xpert Flu+RSV Xpress Assay is acceptable for its intended use with inexperienced lab users.

Table 5-1 shows the similarities and differences between the Xpert Flu+RSV Xpress Assay and the predicate assay, Xpert Flu/RSV XC Assay.

| Similarities | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate Device |
| | Cepheid Xpert Flu+RSV<br>Xpress Assay | Cepheid Xpert Flu/RSV XC<br>Assay |
| 510(k) Number | K151226 | K142045 |
| Regulation | 866.3980 | 866.3980 |
| Product Code | OCC, OOI | OCC, OOI |
| Device Class | Same | II |
| Technology Principle<br>of Operation | Same | Multiplex real time RT-PCR |
| Similarities | | |
| Item | Device | Predicate Device |
| | Cepheid Xpert Flu+RSV<br>Xpress Assay | Cepheid Xpert Flu/RSV XC<br>Assay |
| Intended Use | The Cepheid Xpert Flu+RSV<br>Xpress Assay, performed on<br>the GeneXpert Xpress System,<br>is an automated, multiplex real-<br>time, reverse transcriptase<br>polymerase chain reaction (RT-<br>PCR) assay intended for the <i>in</i><br><i>vitro</i> qualitative detection and<br>differentiation of influenza A,<br>influenza B, and respiratory<br>syncytial virus (RSV) viral<br>RNA. The Xpert Flu+RSV<br>Xpress Assay uses<br>nasopharyngeal swab specimens<br>collected from patients with<br>signs and symptoms of<br>respiratory infection. The Xpert<br>Flu+RSV Xpress Assay is<br>intended as an aid in the<br>diagnosis of influenza and<br>respiratory syncytial virus in<br>conjunction with clinical and<br>epidemiological risk factors. | The Cepheid Xpert Flu/RSV XC<br>Assay is an automated,<br>multiplex real-time, reverse<br>transcriptase polymerase chain<br>reaction (RT-PCR assay<br>intended for the <i>in vitro</i><br>qualitative detection and<br>differentiation of influenza A,<br>influenza B, and respiratory<br>syncytial virus (RSV) viral<br>RNA. The Xpert Flu/RSV XC<br>Assay uses nasopharyngeal<br>swab and nasal aspirate/wash<br>specimens collected from<br>patients with signs and<br>symptoms of respiratory<br>infection in conjunction with<br>clinical and epidemiological risk<br>factors. The Xpert Flu/RSV XC<br>Assay is intended as an aid in<br>the diagnosis of influenza and<br>respiratory syncytial virus. |
| | Negative results do not preclude<br>influenza virus or respiratory<br>syncytial virus infection and<br>should not be used as the sole<br>basis for treatment or other<br>patient management decisions.<br><br>Performance characteristics for<br>influenza A were established<br>during the 2014-2015 influenza<br>season. When other novel<br>influenza A viruses are<br>emerging, performance<br>characteristics may vary. | Negative results do not preclude<br>influenza virus or respiratory<br>syncytial virus infection and<br>should not be used as the sole<br>basis for treatment or other<br>patient management decisions.<br><br>Performance characteristics for<br>influenza A were established<br>during the 2013-2014 influenza<br>season. When other novel<br>influenza A viruses are<br>emerging, performance<br>characteristics may vary. |
| Similarities | | |
| Item | Device | Predicate Device |
| | Cepheid Xpert Flu+RSV<br>Xpress Assay | Cepheid Xpert Flu/RSV XC<br>Assay |
| Intended Use | If infection with a novel<br>influenza A virus is suspected<br>based on current clinical and<br>epidemiological screening<br>criteria recommended by public<br>health authorities, specimens<br>should be collected with<br>appropriate infection control<br>precautions for novel virulent<br>influenza viruses and sent to<br>state or local health department<br>for testing. Viral culture should<br>not be attempted in these cases<br>unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. | If infection with a novel<br>influenza A virus is suspected<br>based on current clinical and<br>epidemiological screening<br>criteria recommended by public<br>health authorities, specimens<br>should be collected with<br>appropriate infection control<br>precautions for novel virulent<br>influenza viruses and sent to<br>state or local health department<br>for testing. Viral culture should<br>not be attempted in these cases<br>unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. |
| Indication for Use | Same | Patients with signs and<br>symptoms of respiratory<br>infection in conjunction with<br>clinical and epidemiological risk<br>factors. |
| Assay Targets | Same | Influenza A Virus, Influenza B<br>Virus, and RSV viral RNA |
| Specimen Types | Nasopharyngeal (NP) swab<br>specimens | Nasopharyngeal (NP) swab<br>specimens and<br>Nasal aspirate/wash (NA/W)<br>specimens |
| Nucleic Acid<br>Extraction | Yes | Yes |
| Extraction Methods | Sample preparation integrated in<br>GeneXpert Cartridge and<br>GeneXpert Xpress System | Sample preparation integrated in<br>GeneXpert Cartridge and<br>GeneXpert Instrument System |
| Assay Results | Same | Qualitative |
| Instrument System | Cepheid GeneXpert Xpress<br>System (instrument model<br>GX-I); same Cepheid I-core<br>technology | Cepheid GeneXpert Instrument<br>Systems (various instrument<br>models including instrument<br>model GX-I); Cepheid I-core<br>technology |
| Similarities | | |
| Item | Device | Predicate Device |
| | Cepheid Xpert Flu+RSV<br>Xpress Assay | Cepheid Xpert Flu/RSV XC<br>Assay |
| Assay Controls | Same | Encapsulated (armored) RNA<br>pseudovirus as a sample<br>processing control.<br>Available but not provided are<br>inactivated virus controls for<br>influenza A/B and RSV as<br>external positive controls, and<br>Coxsackie virus as an external<br>negative control. |
| Time to obtain test<br>results | Approximately 60 minutes for<br>sample preparation and real-<br>time RT-PCR. | Approximately 60 minutes or<br>less for sample preparation and<br>real-time RT-PCR. |
| Primers and probes | Same | Primers and probes to detect the<br>presence of nucleic acid<br>sequences of influenza A,<br>influenza B, and RSV. |

#### Table 5-1: Comparison of Similarities and Differences of the Xpert Flu+RSV Xpress Assay with the Predicate Device

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| Primary Differences<br>(Differences are also Captured in the Similarities Table above) | | | | |
|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--|--|
| | New Device | Predicate Device | | |
| Item | Cepheid Xpert Flu+RSV<br>Xpress Assay | Cepheid Xpert Flu/RSV XC<br>Assay | | |
| Instrument System | Cepheid GeneXpert Xpress<br>System | Cepheid GeneXpert Dx<br>Systems and GeneXpert<br>Infinity Systems | | |
| Laboratory Users | Untrained operators with no<br>clinical lab experience in a<br>CLIA-waiver environment. | Operators with no clinical lab<br>experience to experienced<br>clinical laboratory<br>technologists. | | |
| Combinatorial Assay<br>Selections | No combinatorial assay<br>selections are available. | Yes, user may select combined<br>assay with all targets or a Flu<br>only assay or a RSV only<br>assay. | | |
| Early assay<br>termination function | No early assay termination<br>function is available. | Yes, on Flu only or RSV only<br>assay selections. | | |

The Xpert Flu+RSV Xpress Assay has the same general intended use as the predicate device and has the same technological characteristics as the predicate device. The differences between the Xpert Flu+RSV Xpress Assay and the predicate device do not raise different questions of safety and effectiveness. The clinical study demonstrates that the Xpert Flu+RSV Xpress Assay is acceptable for its intended use with inexperienced laboratory users and is substantially equivalent to the predicate device described above.

## Xpert Nasopharyngeal Sample Collection Kit

The predicate device for the ancillary specimen collection kit, the Xpert® Nasopharyngeal Sample Collection Kit, is the Cepheid Nasopharyngeal Sample Collection Kit, [510(k) # K042970]. The similarities and differences are shown in Table 5-2.

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| Sample Collection Kit with the Predicate Device<br>Similarities | | |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device | Predicate |
| Item | Xpert Nasopharyngeal Sample<br>Collection Kit | Xpert Nasopharyngeal Sample<br>Collection Kit |
| Intended Use<br>(Similarities) | For collection, preservation<br>and transport of<br>nasopharyngeal swab<br>specimens and to preserve and<br>transport nasal aspirate/wash<br>specimens containing viruses<br>from patients with signs and<br>symptoms of respiratory<br>infection prior to analysis with<br>the Xpert Flu Assay and the<br>Xpert Flu/RSV XC Assay.<br>For collection, preservation and<br>transport of nasopharyngeal<br>swab specimens containing<br>viruses from patients with signs<br>and symptoms of respiratory<br>infection prior to analysis with<br>the Xpert Flu+RSV Xpress<br>Assay. | For collection, preservation<br>and transport of<br>nasopharyngeal swab<br>specimens and to preserve and<br>transport nasal aspirate/wash<br>specimens containing viruses<br>from patients with signs and<br>symptoms of respiratory<br>infection prior to analysis with<br>the Xpert Flu Assay and the<br>Xpert Flu/RSV XC Assay. |
| Single-use Device | Yes | Yes |
| Medium Formulation | Same | Hank's Balanced Salt Solution<br>Bovine Serum Albumin<br>L-cysteine<br>Gelatin<br>Sucrose<br>L-glutamic acid<br>HEPES buffer<br>Vancomycin<br>Amphotericin B<br>Colistin<br>Phenol red |
| pH | Same | $7.3 \pm 0.2$ |

Table 5-2: Comparison of Similarities and Differences of the Xpert Nasopharyngeal
Sample Collection Kit with the Predicate Device

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| Similarities | | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------…