Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

K162331 · Cepheid · OCC · Feb 9, 2017 · Microbiology

Device Facts

• Record ID: K162331
• Device Name: Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
• Applicant: Cepheid
• Product Code: OCC · Microbiology
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The Cepheid Xpert® Xpress Flu/RSV Assay, performed on the GeneXpert® Instrument Systems, 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 Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu/RSV 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 RSV 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 2015-2016 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

Automated, multiplex real-time RT-PCR assay for qualitative detection/differentiation of Flu A, Flu B, and RSV viral RNA. Input: nasopharyngeal (NP) swab specimens in viral transport medium. Process: specimen transferred to self-contained GeneXpert cartridge; GeneXpert Instrument System performs automated sample processing, nucleic acid extraction, and real-time RT-PCR amplification/hybridization. Output: qualitative test results generated in ~30 minutes. Used in moderate/high complexity laboratory settings by lab personnel. Results aid clinical diagnosis in conjunction with risk factors. Benefits: rapid, automated, hands-off processing; reduces turnaround time compared to traditional methods; internal controls (SPC, PCC) ensure processing quality and monitor for inhibitors.

Clinical Evidence

Multi-center study (11 US sites, 2015-2016 season) compared Xpert Xpress Flu/RSV to FDA-cleared molecular comparator. Combined dataset (N=2065 NP swabs: 1142 fresh, 923 frozen) showed PPA/NPA: Flu A (98.1%/98.4%), Flu B (100%/98.7%), RSV (98.5%/98.8%). Assay success rate 99.7%. Reproducibility study confirmed performance across sites, operators, and systems.

Technological Characteristics

Multiplex real-time RT-PCR; GeneXpert I-core technology. Self-contained, single-use plastic (polypropylene) cartridges. Internal controls: Sample Processing Control (SPC) and Probe Check Control (PCC). Targets: Flu A (MP, PB2, PA), Flu B (MP, NS1, NS2), RSV A/B (Nucleocapsid). Automated extraction and amplification.

Indications for Use

Indicated for patients with signs and symptoms of respiratory infection to aid in diagnosis of influenza A, influenza B, and RSV infections. Uses nasopharyngeal (NP) swab specimens. Not for sole basis of treatment/management 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

• Xpert® Flu/RSV XC Assay (K142045)
• Cepheid Xpert Nasopharyngeal Sample Collection Kit (K151226)

Reference Devices

• Prodesse ProFlu+ Assay (K132129)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, resembling a bird-like shape.

February 9, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

Public Health Service

CEPHEID SCOTT A. CAMPBELL CORPORATE VICE PRESIDENT & CHIEF REGULTORY OFFICER 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089

Re: K162331 Trade/Device Name: Xpert® Xpress Flu/RSV Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC, OOI, JSM Dated: August, 18 2016 Received: August 23, 2016

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 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/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,

# Steven R. Gitterman -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)

K162331

Device Name

Xpert Xpress Flu/RSV

#### Indications for Use (Describe)

The Cepheid Xpert® Xpress Flu/RSV Assay, performed on the GeneXpert® Instrument Systems, is an automated, multiplex real-time, reverse transcriptase 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 Xpress Flu/ RSV Assay uses nasopharyngeal (NP) swab specimens with signs and symptoms of respiratory infection. The Xpert Xpress Flu/RSV Assav 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 RSV 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 2015-2016 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 Kit Indications for Use:

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 or the Xpert Xpress Flu/RSV 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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### 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: | August 18, 2016 |
| Device: | |
| Trade name: | Xpert® Xpress Flu/RSV |
| Common name: | Xpert Xpress Flu/RSV Assay |
| Type of Test: | Automated, multiplex real-time reverse transcription-<br>polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A,<br>influenza B, and respiratory syncytial virus (RSV) viral RNA. |
| Regulation number/<br>Classification name/<br>Product code: | 866.3980/Respiratory viral panel multiplex nucleic acid<br>assay/OCC<br>866.2570/Instrumentation for clinical multiplex test<br>systems/OOI<br>866.2390/Culture Media, Non-propagating<br>Transport/JSM |
| Classification<br>Advisory Panel | Class II<br>Microbiology (83) |
| Prescription Use | Yes |
| Predicate Devices<br>Assay: | 1) For the detection and differentiation of influenza A,<br>influenza B, and RSV A/B viral RNA in nasopharyngeal<br>swab specimens:<br>Xpert® Flu/RSV XC Assay [510(k) #K142045]<br><br>2) For the Sample Collection Kits:<br><br>Cepheid Xpert Nasopharyngeal Sample Collection Kit |

[510(k) # K151226]

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### Device Description:

The Xpert Xpress Flu/RSV Assay is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV) viral RNA directly from nasopharyngeal (NP) swab specimens. The assay is performed on the Cepheid GeneXpert® Instrument Systems.

The Xpert Xpress Flu/RSV Assay includes reagents for the simultaneous detection and differentiation of the target viruses. The primers and probes in the Xpert Xpress Flu/RSV Assay detect the presence of nucleic acid sequences for Flu A, Flu B, and RSV directly from 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 internal controls utilized by the GeneXpert Instrument System platform. The SPC is present in every assay to control for adequate processing of the target viruses and to monitor for the presence of inhibitor(s) in the PCR assay to avoid false-negative results. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability.

The specimens are collected in viral transport medium and transported to the GeneXpert area. The specimen is prepared according to package insert instructions and transferred to the sample chamber (large opening) of the Xpert Xpress Flu/RSV Assay cartridge. The GeneXpert cartridge is loaded onto the GeneXpert Instrument System platform, which performs hands-off automated sample processing and real-time RT-PCR for detection of Flu and RSV viral RNA. Summary and detailed test results are obtained in approximately 30 minutes or less. 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:

The Cepheid Xpert® Xpress Flu/RSV Assay, performed on the GeneXpert® Instrument Systems, 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 Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu/RSV 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 RSV 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 2015-2016 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 Specimen 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

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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 or the Xpert Xpress Flu/RSV Assay.

#### Substantial Equivalence:

The Xpert Xpress Flu/RSV Assay is substantially equivalent to the current Xpert® Flu/RSV XC Assay [510(k) #K142045]. The Xpert Xpress Flu/RSV Assay detects influenza A. influenza B. and RSV A/B from nasopharyngeal (NP) swab specimens and the Xpert® Flu/RSV XC Assay detects influenza A, influenza B, and RSV from both NP swab specimens and nasal aspirates/washes (NA/W) specimens. Both assays utilize the same technology by determining the presence of the target organisms through real-time RT-PCR amplification and fluorogenic target-specific hybridization detection. A multicenter clinical study was conducted to determine the performance characteristics of the Xpert Xpress Flu/RSV Assay relative to the predicate device, which has been FDA cleared for NP swab and NA/W specimens. Discordant results between the Xpert Xpress Flu/RSV Assay and the reference method Prodesse ProFlu+ Assay [510(k) # K132129] were analyzed by bi-directional sequencing using primers different from those used in the Xpert Xpress Flu/RSV Assay. The study results showed that the Xpert Xpress Flu/RSV Assay is substantially equivalent to the predicate device.

Table 8-1 shows the similarities and differences between the Xpert Xpress Flu/RSV Assay and the predicate devices.

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| Similarities | | |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress<br>Flu/RSV | Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| Regulation | 866.3980 | Same |
| Product Code | OCC, OOI | Same |
| Device Class | II | Same |
| Technology<br>Principle of<br>Operation | Multiplex real time RT-PCR | Same |
| Intended Use | The Cepheid Xpert® Xpress<br>Flu/RSV Assay, performed on<br>the GeneXpert Instrument<br>Systems, is an automated,<br>multiplex real-time, reverse<br>transcriptase polymerase<br>chain reaction (RT-PCR)<br>assay intended for the <i>in vitro</i><br>qualitative detection and<br>differentiation of<br>influenza A, influenza B, and<br>respiratory syncytial virus<br>(RSV) viral RNA. The Xpert<br>Xpress Flu/RSV Assay uses<br>nasopharyngeal (NP) swab<br>specimens collected from<br>patients with signs and<br>symptoms of respiratory<br>infection. The Xpert Xpress<br>Flu/RSV Assay is intended as<br>an aid in the diagnosis of<br>influenza and respiratory<br>syncytial virus infections in<br>conjunction with clinical and<br>epidemiological risk factors.<br>Negative results do not | The Cepheid Xpert® Flu/RSV<br>XC 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<br>influenza A, influenza B, and<br>respiratory syncytial virus<br>(RSV) viral RNA. The Xpert<br>Flu/RSV XC Assay uses<br>nasopharyngeal swab and<br>nasal aspirate/wash specimens<br>collected from patients with<br>signs and symptoms of<br>respiratory infection. The<br>Xpert Flu/RSV XC Assay is<br>intended as an aid in the<br>diagnosis of influenza and<br>respiratory syncytial virus<br>infections in conjunction with<br>clinical and epidemiological<br>risk factors.<br>Negative results do not |
| Similarities | | |
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress<br>Flu/RSV | Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| | preclude influenza virus or<br>RSV<br>infection and should not be<br>used as the sole basis for<br>treatment or other patient<br>management decisions. | preclude influenza virus or<br>respiratory syncytial virus<br>infection and should not be<br>used as the sole basis for<br>treatment or other patient<br>management decisions. |
| | Performance characteristics<br>for influenza A were<br>established during the 2015-<br>2016 influenza season. When<br>other novel influenza A<br>viruses are emerging,<br>performance characteristics<br>may vary. | Performance characteristics for<br>influenza A were established<br>during the 2013-2014<br>influenza season. When other<br>novel influenza A viruses are<br>emerging, performance<br>characteristics may vary. |
| | If infection with a novel<br>influenza A virus is suspected<br>based on current clinical and<br>epidemiological screening<br>criteria recommended by<br>public health authorities,<br>specimens should be collected<br>with appropriate infection<br>control precautions for novel<br>virulent influenza viruses and<br>sent to state or local health<br>departments for testing. Viral<br>culture should not be<br>attempted in these cases<br>unless a BSL 3+ facility is<br>available to receive and<br>culture 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<br>public health authorities,<br>specimens should be collected<br>with appropriate infection<br>control precautions for novel<br>virulent influenza viruses and<br>sent to state or local health<br>departments for testing. Viral<br>culture should not be<br>attempted in these cases unless<br>a BSL 3+ facility is available<br>to receive and culture<br>specimens. |
| Similarities | | |
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress<br>Flu/RSV | Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| Indications for<br>Use | Patients with signs and<br>symptoms of respiratory<br>infection in conjunction with<br>clinical and epidemiological<br>risk factors | Same |
| Assay Targets | Influenza A Virus, Influenza<br>B Virus, and RSV viral RNA | Same |
| Nucleic Acid<br>Extraction | Yes | Same |
| Extraction<br>Methods | Sample preparation integrated<br>in GeneXpert Cartridge and<br>GeneXpert Instrumentation<br>System | Same |
| Assay Results | Qualitative | Same |
| Instrument<br>System | Cepheid GeneXpert<br>Instrument Systems; same<br>Cepheid I-core technology | Same |
| Assay Controls | 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. | Same |
| Primers and<br>probes | Primers and probes to detect<br>the presence of nucleic acid<br>sequences of influenza A,<br>influenza B, and RSV. | Primers and probes to detect<br>the presence of influenza A,<br>influenza A subtype H7N9,<br>influenza B and RSV. |
| Laboratory<br>Users | Laboratory users in moderate<br>and high complexity<br>laboratory settings. | Same |
| Similarities | | |
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress<br>Flu/RSV | Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| Sample<br>Preparation | Self-contained and automated<br>after mixed specimen is added<br>to cartridge. All other<br>reagents are contained in the<br>cartridge. | Same |
| Primers and<br>probes for<br>influenza A,<br>influenza B,<br>and influenza<br>A subtype<br>H1N1 | Primers and probes to detect<br>the presence of nucleic acid<br>sequences of influenza A,<br>influenza B, and RSV A/B.<br>The Xpert Xpress Flu/RSV<br>Assay contains primers and<br>probes to detect additional<br>RNA segments in order to<br>protect the assay sensitivity<br>and specificity from mutations<br>in the influenza genome due<br>to antigenic drifts and shifts. | Primers and probes to detect<br>the presence of nucleic acid<br>sequences of influenza A,<br>influenza B, and RSV A/B.<br>The Xpert Flu/RSV XC Assay<br>contains primers and probes to<br>detect additional RNA<br>segments in order to protect<br>the assay sensitivity and<br>specificity from mutations in<br>the influenza genome due to<br>antigenic drifts and shifts. |
| Target<br>Sequence | Influenza A: Matrix protein<br>(MP),basic polymerase (PB2)<br>and acidic protein (PA)<br>Influenza B: Matrix protein<br>(MP) and Non-structural<br>proteins (NS 1 and NS 2)<br>RSV A and RSV B:<br>Nucleocapsid protein | Same |
| Internal<br>Controls | Sample processing control<br>(SPC) and probe check<br>control (PCC). | Same |
| Combinatorial<br>Assay<br>Selections | Yes, user may select<br>combined assay with all<br>targets or a Flu only assay or a<br>RSV only assay. | Same |
| Early assay<br>termination<br>function | On Flu only or RSV only<br>assay selections | Same |
| Differences | | |
| | Device | Predicate |
| Item | Cepheid Xpert Flu/RSV XC | Cepheid Xpert Flu/RSV XC…