Xpert Xpress Flu, 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

K162456 · Cepheid · OCC · Feb 13, 2017 · Microbiology

Device Facts

• Record ID: K162456
• Device Name: Xpert Xpress Flu, 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 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The Cepheid Xpert® Xpress Flu 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 and influenza B viral RNA. The Xpert Xpress Flu Assay uses nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu Assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza 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 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

The Xpert Xpress Flu Assay is an automated, in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viral RNA. It utilizes nasopharyngeal (NP) swab specimens collected in viral transport medium. The assay is performed on Cepheid GeneXpert Instrument Systems. The process involves loading the specimen into a self-contained cartridge; the system performs automated sample processing, nucleic acid extraction, and real-time RT-PCR amplification. The system uses internal controls (Sample Processing Control and Probe Check Control) to monitor processing and reagent integrity. Results are generated in approximately 30 minutes or less. The device is used in clinical laboratory settings by trained personnel. Healthcare providers use the output to aid in the diagnosis of influenza infections. The device benefits patients by providing rapid, accurate identification of influenza A and B, facilitating timely clinical decision-making and patient management.

Clinical Evidence

Clinical performance evaluated at 11 U.S. sites during the 2015-2016 season using 2,065 NP swab specimens (1,142 fresh, 923 frozen). Combined dataset PPA/NPA: Flu A (98.1%/98.4%), Flu B (100%/98.7%). Reproducibility study across three sites and three systems (GeneXpert Dx, Infinity-48, Infinity-80) showed high agreement (93.7%-100% for positives, 100% for negatives). Analytical studies confirmed LoD, specificity (100% against 44 respiratory pathogens), and inclusivity across multiple influenza strains.

Technological Characteristics

Multiplex real-time RT-PCR assay. Uses Cepheid GeneXpert Instrument Systems with I-core technology. Self-contained, single-use plastic (polypropylene) cartridges. Integrated automated nucleic acid extraction and amplification. Internal controls: Sample Processing Control (SPC) and Probe Check Control (PCC). Targets: Influenza A (MP, PB2, PA genes) and Influenza B (MP, NS1, NS2 genes). Connectivity: Standalone instrument system. Sterilization: Not specified.

Indications for Use

Indicated for patients with signs and symptoms of respiratory infection to detect and differentiate influenza A and B viral RNA from nasopharyngeal (NP) swab specimens. Intended as an aid in diagnosis in conjunction with clinical/epidemiological risk factors. Not for sole basis of patient management.

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 a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

February 13, 2017

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

Cepheid Jim Kellv. PhD Executive Director, Regulatory Affairs 904 Caribbean Drive Sunnyvale, CA 94089

Re: K162456

Trade/Device Name: Xpert® Xpress Flu Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC. OOI. JSM Dated: January 10, 2017 Received: January 11, 2017

Dear Dr. Kelly:

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,

# 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)

K162456

Device Name

Xpert Xpress Flu

#### Indications for Use (Describe)

The Cepheid Xpert Xpress Flu 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 virro qualitative detection and differentiation of influenza B viral RNA. The Xpert Xpress Flu Assay uses nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu Assay is intended as an aid in the diagnosis of influenza infections in clinical and epidemiological risk factors.

Negative results do not preclude influenza 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 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, Xpert Xpress Flu/RSV Assay or the Xpert Xpress Flu Assay.

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

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

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#### 8.0 510(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: | September 01, 2016 |
| Device: | |
| Trade name: | Xpert® Xpress Flu |
| Common name: | Xpert Xpress Flu Assay |
| Type of Test: | Automated, multiplex real-time reverse transcription-<br>polymerase chain reaction (RT-PCR) assay intended for the in<br>vitro qualitative detection and differentiation of influenza A<br>and influenza B viral RNA. |
| Regulation number/<br>Classification name/ | 866.3980/Respiratory viral panel multiplex nucleic acid<br>assay/OCC |
| Product code: | 866.2570/Instrumentation for clinical multiplex test<br>systems/OOI |
| | 866.2390/Culture Media, Non-Propagating<br>Transport |
| Classification | Class II |
| Advisory Panel | 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] |
| | 2) For the Sample Collection Kits:<br>Cepheid Xpert® Nasopharyngeal Sample Collection Kit<br>[510(k) # K151226] |

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#### Device Description:

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

The Xpert Xpress Flu Assay includes reagents for the simultaneous detection and differentiation of the target viruses. The primers and probes in the Xpert Xpress Flu Assay detect the presence of nucleic acid sequences for Flu A and Flu B 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 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 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 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 and influenza B viral RNA. The Xpert Xpress Flu Assay uses nasopharyngeal (NP) swab specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Xpress Flu Assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude influenza 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 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, Xpert Xpress Flu/RSV Assay or the Xpert Xpress Flu Assay.

#### Substantial Equivalence:

The Xpert Xpress Flu Assay is substantially equivalent to the current Xpert® Flu/RSV XC Assay [510(k) #K142045]. The Xpert Xpress Flu Assay detects influenza A and influenza 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 aspirate/wash (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 multi-center clinical study was conducted and obtained data using the Xpert Xpress Flu/RSV Assay which was then reanalyzed with the Xpert Xpress Flu Assay Definition File (ADF). The reanalyzed data was used to determine the performance characteristics of the Xpert Xpress Flu 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 Assay and the reference method Prodesse ProFlu+ Assay [510(k) #K132129] were analyzed by bidirectional sequencing using primers different from those used in the Xpert Xpress Flu Assay. The study results showed that the Xpert Xpress Flu Assay is substantially equivalent to the predicate device.

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

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| Similarities | | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress Flu | 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 Assay, performed on the<br>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 in vitro<br>qualitative detection and<br>differentiation of influenza A<br>and influenza B viral RNA.<br>The Xpert Xpress Flu Assay<br>uses nasopharyngeal (NP)<br>swab specimens collected<br>from patients with signs and<br>symptoms of respiratory<br>infection. The Xpert Xpress<br>Flu Assay is intended as an<br>aid in the diagnosis of<br>influenza infections in<br>conjunction with clinical and<br>epidemiological risk factors.<br>Negative results do not<br>preclude influenza virus<br>infection and should not be | 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 in vitro<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 Flu | Cepheid Xpert® Flu/RSV XC |
| | | 510(k)# K142045 |
| | used as the sole basis for<br>treatment or other patient<br>management decisions.<br>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.<br>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. | 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.<br>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.<br>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 | | |
| Item | Device<br>Cepheid Xpert® Xpress Flu | Predicate<br>Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| Indications for Use | Patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors | Same |
| Nucleic Acid Extraction | Yes | Same |
| Extraction Methods | Sample preparation integrated in GeneXpert Cartridge and GeneXpert Instrumentation System | Same |
| Assay Results | Qualitative | Same |
| Instrument System | Cepheid GeneXpert Instrument Systems; same Cepheid I-core technology | Same |
| Primers and probes | Primers and probes to detect the presence of nucleic acid sequences of influenza A, influenza B, and RSV. Only results for influenza A and influenza B are reported. | Primers and probes to detect the presence of influenza A, influenza A subtype H7N9, influenza B and RSV. Results for influenza A, influenza B and RSV analytes are reported. |
| Laboratory Users | Laboratory users in moderate and high complexity laboratory settings. | Same |
| Sample Preparation | Self-contained and automated after mixed specimen is added to cartridge. All other reagents are contained in the cartridge. | Same |
| Similarities | | |
| Item | Device<br>Cepheid Xpert® Xpress Flu | Predicate<br>Cepheid Xpert® Flu/RSV XC<br>510(k)# K142045 |
| Primers and<br>probes for<br>influenza A,<br>influenza B | 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 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.<br>Only results for influenza A<br>and influenza B are reported. | 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>Sequences | Influenza A: Matrix protein<br>(MP),basic polymerase (PB2)<br>and acidic protein (PA)<br><br>Influenza B: Matrix protein<br>(MP) and Non-structural<br>proteins (NS 1 and NS 2)<br><br>RSV A and RSV B:<br>Nucleocapsid protein<br><br>Only results for influenza A<br>and influenza B are reported. | Influenza A: Matrix protein<br>(MP),basic polymerase (PB2)<br>and acidic protein (PA)<br><br>Influenza B: Matrix protein<br>(MP) and Non-structural<br>proteins (NS 1 and NS 2)<br><br>RSV A and RSV B:<br>Nucleocapsid protein |
| Internal<br>Controls | Sample processing control<br>(SPC) and probe check<br>control (PCC). | Same |
| Early assay<br>termination<br>function | Yes | Yes |
| Differences | | |
| | Device | Predicate |
| Item | Cepheid Xpert® Xpress Flu | Cepheid Xpert® Flu/RSV XC |
| Assay Targets | Influenza A Virus and<br>Influenza B Virus viral RNA | Influenza A Virus, Influenza B<br>Virus, and RSV viral RNA |
| Specimen<br>Types | Nasopharyngeal (NP) swab<br>specimens | Nasal aspirate/wash (NA/W)<br>specimens and<br>Nasopharyngeal (NP) swab<br>specimens |
| Assay Controls | Encapsulated (armored) RNA<br>pseudovirus as a sample<br>processing control.…