Who is the manufacturer of XPERT FLU/RSV XC ASSAY?

Cepheid filed the 510(k) submission for XPERT FLU/RSV XC ASSAY (K142045).

What is the FDA product code for XPERT FLU/RSV XC ASSAY?

OCC. It is classified under 21 CFR 866.3980 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for XPERT FLU/RSV XC ASSAY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for XPERT FLU/RSV XC ASSAY?

Hologic Prodesse ProFlu+ Assay (K110968, K132129); Cepheid Xpert Flu (K123191); Copan Universal Transport Medium (UTM-RT) System (K042970).

Who can help prepare an FDA 510(k) submission like XPERT FLU/RSV XC ASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XPERT FLU/RSV XC ASSAY

K142045 · Cepheid · OCC · Nov 22, 2014 · Microbiology

Device Facts

Record ID	K142045
Device Name	XPERT FLU/RSV XC ASSAY
Applicant	Cepheid
Product Code	OCC · Microbiology
Decision Date	Nov 22, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3980
Device Class	Class 2

Intended Use

The Cepheid Xpert Flu/RSV XC Assay 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 XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu/RSV XC 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 2013-2014 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.

Device Story

Automated, multiplex RT-PCR assay for qualitative detection/differentiation of influenza A, influenza B, and RSV viral RNA. Input: nasopharyngeal swab or nasal aspirate/wash specimens. Process: GeneXpert instrument system automates sample purification, nucleic acid amplification, and real-time detection within single-use, multi-chambered fluidic cartridges. Features ultrasonic lysis and I-CORE thermocycler. Output: automated report viewed/printed by clinician. Used in clinical labs (moderate/high complexity) by technologists. Aids diagnosis in conjunction with clinical/epidemiological risk factors; negative results do not rule out infection. Benefits: rapid (approx. 60 min) diagnosis, reduced cross-contamination via self-contained cartridge, and integrated sample processing.

Clinical Evidence

Multi-center clinical study (2013-2014 season) compared Xpert Flu/RSV XC to FDA-cleared comparator. Tested 657 NA/W and 593 NP swab specimens (fresh and frozen). For fresh NA/W: Flu A PPA 100%, Flu B PPA 99.2%, RSV PPA 98.5%. For fresh NP swabs: Flu A PPA 85.7%, Flu B PPA 100%, RSV PPA 100%. Discrepant results analyzed by bi-directional sequencing.

Technological Characteristics

Multiplex real-time RT-PCR assay. Materials: medical-grade polypropylene cartridges. Sensing: fluorogenic target-specific hybridization. Energy: electrical (GeneXpert instrument). Connectivity: standalone instrument system. Sterilization: N/A (disposable cartridge). Software: automated analysis of Ct values.

Indications for Use

Indicated for symptomatic patients (nasopharyngeal swab or nasal aspirate/wash specimens) to aid in diagnosis of influenza A, influenza B, and RSV infections. Not for use as sole basis for treatment decisions. Performance for novel influenza A may vary.

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

Hologic Prodesse ProFlu+ Assay (K110968, K132129)
Cepheid Xpert Flu (K123191)
Copan Universal Transport Medium (UTM-RT) System (K042970)

Related Devices

K162331 — 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 · Cepheid · Feb 9, 2017
K231481 — Xpert Xpress CoV-2/Flu/RSV plus · Cepheid® · Aug 17, 2023
K151226 — Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) · Cepheid · Dec 3, 2015
K250996 — Xpert Xpress CoV-2/Flu/RSV plus · Cepheid® · May 1, 2025
K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System · Roche Molecular Systems, Inc. · Jul 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Cepheid Scott Campbell, Ph.D., MBA Executive Director, Clinical Affairs 904 Caribbean Drive Sunnyvale CA 94089-1189 November 22, 2014 Re: K142045 Trade/Device Name: Xpert® Flu/RSV XC Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC, OOI Dated: October 21, 2014 Received: October 22, 2014 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 (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. {1}------------------------------------------------ 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Uwe Scherf -S for Sally A. Hojvat Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142045 Device Name Cepheid Xpert® Flu/RSV XC Assay ### Indications for Use (Describe) The Cepheid Xpert Flu/RSV XC Assay 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 B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu/RSV XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu/RSV XC 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 2013-2014 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. Type of Use (Select one or both, as applicable) | <div> 区 Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 5.0 510(k) Summary As required by 21 CFR Section 807.92(c). | Submitted by: | Cepheid 904 Caribbean Drive Sunnyvale, CA 90489 Phone number: (408) 400-8460 Fax number: (847) 510-0539 | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Kerry J. Flom, Ph.D. | | Date of Preparation: | November 17, 2014 | | Device: | | | Trade name: | Xpert® Flu/RSV XC | | Common name: | Xpert Flu/RSV XC Assay | | Type of Test: | Automated, multiplex real-time reverse transcription- polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus. | | Regulation number/ Classification name/ Product code: | 866.3980/Respiratory viral panel multiplex nucleic acid assay/OCC 866.2570/Instrumentation for clinical multiplex test systems/OOI | | Classification | Class II | | Advisory Panel | Microbiology (83) | | Prescription Use | Yes | | Predicate Devices Assay: | 1) For the detection and differentiation of influenza A, influenza B, and RSV A/B viral RNA in nasopharyngeal swab specimens: Hologic Prodesse® ProFlu™+ Assay (ProFlu+ Assay) [510(k) #K1109668 and Special 510(k) #K132129]; and, 2) For the detection and differentiation of influenza A and influenza B viral RNA in nasal aspirate/wash and nasopharyngeal swab specimens: Cepheid Xpert Flu [510(k) #K123191]. | | Predicate Devices Ancillary Sample Collection Kit: | Copan Universal Transport Medium (UTM-RT) System [510(k) #K042970] | {4}------------------------------------------------ ### Device Description: The Xpert Flu/RSV XC Assay is a rapid, 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 Instrument Systems (GeneXpert Dx systems and GeneXpert Infinity Systems). The GeneXpert Instrument System platform automates and integrates sample purification, nucleic acid 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 singleuse disposable cartridges (the Xpert Flu/RSV XC 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 XC Assay includes reagents for the detection and differentiation of influenza A, influenza B, and RSV viral RNA directly from nasopharyngeal (NP) swab and nasal aspirate/wash (NA/W) 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 A, influenza B and RSV viral RNA in approximately 60 minutes or less. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each 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 real-time PCR and RT-PCR and detection. Specimens are collected following the user's institution standard procedures for collecting NA/W specimens and NP swab specimens for influenza and RSV testing. The ancillary Cepheid Xpert Nasopharyngeal Sample Collection Kit (Cepheid catalog #SWAB/B-100) or Cepheid's Sample Collection Kit (Cepheid catalog #NASL-100N-100) are required but not provided for use with the assay. Both kits contain the identical viral transport medium and sterile nylon flocked swab. The NA/W specimen or the NP swab specimen is placed into the Xpert viral transport medium and sent to the GeneXpert® testing area for processing. When stored in the transport medium, the NA/W specimen or NP swab specimen is stable for up to 24 hours at 2-30 ℃ or up to seven days at 2-8 ℃. 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 {5}------------------------------------------------ top of the disposable fluidic cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert 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. ## Device Intended Use: The Cepheid Xpert Flu/RSV XC Assay 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 B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu/RSV XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu/RSV XC 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 2013-2014 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. Ancillary Specimen Collection Kit 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 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 has only been cleared for use with the Xpert Flu Assay and Xpert Flu/RSV XC Assays. {6}------------------------------------------------ ### Substantial Equivalence: The Xpert Flu/RSV XC Assay is substantially equivalent to the ProFlu+ Assay [510(k) # K110968 and #K132139] and to the current Cepheid Xpert Flu Assay (510(k) #K123191). The ProFlu+ Assay and the Xpert Flu/RSV XC Assay detect influenza A, influenza B. and RSV A/B from NP swab specimens. The Xpert Flu Assay detects influenza A and B from both NP swab specimens and NA/W specimens, and the Xpert Flu/RSV XC Assay detects influenza A. influenza B. and RSV from both NP swab specimens and NA/W specimens. All three 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 to determine the performance characteristics of the device relative to the primary predicate device, the ProFlu+ Assay, which was validated for use with NA/W specimens, and FDA cleared for NP swab specimens. Discordant results between the Xpert Flu/RSV XC Assay and the ProFlu+ Assay were analyzed by sequencing using primers different from those used in the Xpert Flu/RSV XC Assay. The study results showed the Xpert Flu/RSV XC Assay is acceptable for its intended use and is substantially equivalent to the predicate devices. Table 5-1 shows the similarities and differences between the Xpert Flu/RSV XC Assav and the predicate assays. | Similarities | | | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device | Predicate Devices | | | Item | Cepheid Xpert Flu/RSV XC | Current Cepheid Xpert Flu | Hologic Prodesse ProFlu+ Assay | | 510(k) Number | #K142045 | #K123191 | #K110968 and #K132129 (special) | | Regulation | 866.3980 | Same | Same | | Product Code | OCC, OOI | OQW, OCC, OOI | OCC, OOI | | Device Class | II | Same | Same | | Technology Principle of Operation | Multiplex real time RT- PCR | Same | Same | | Similarities | | | | | | Device | Predicate Devices | | | Item | Cepheid Xpert Flu/RSV XC | Current Cepheid Xpert Flu | Hologic Prodesse ProFlu+ Assay | | Intended Use | The Cepheid Xpert Flu/RSV XC 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 Flu/RSV XC Assay uses nasopharyn- geal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The Xpert Flu/RSV XC Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus. | The Cepheid Xpert Flu Assay, performed on the GeneXpert Instrument Systems, is an automated, multiplex real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B and 2009 H1N1 influenza viral RNA. The Xpert Flu Assay uses nasal aspirates/washes and nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The Xpert Flu Assay is intended as an aid in the diagnosis of influenza. | The ProFlu™+ Assay is a multiplex Real- Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C. | | | 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. | Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. | Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or | | Similarities | | | | | | Device | Predicate Devices | | | Item | Cepheid Xpert Flu/RSV XC | Current Cepheid Xpert Flu | Hologic Prodesse ProFlu+ Assay | | | | | 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 were established during the 2013-2014 influenza season. When other novel influenza A viruses are emerging, performance characteristics may vary. | Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 H1N1 influenza was the predominant influenza A virus in circulation. Performance characteristics for influenza A were confirmed when influenza A/H3 and influenza A/2009 H1N1 were the predominant influenza A viruses in circulation (2009-2010, 2010-2011 and 2011-2012). When other influenza A viruses are emerging, performance characteristics may vary. | Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation (2006 - 2007 respiratory season). Performance characteristics for Influenza A were confirmed when Influenza A/H1, Influenza A/H3, and Influenza A/2009 H1N1 were the predominant Influenza A viruses in circulation (2008 and 2009). When other Influenza A viruses are emerging, performance characteristics may vary. | | Similarities | | | | | | Device | Predicate Devices | | | Item | Cepheid Xpert Flu/RSV XC | Current Cepheid Xpert Flu | Hologic Prodesse ProFlu+ Assay | | | 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. | 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. | 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. | | Indication for Use | Patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors | Same as Xpert Flu/RSV XC Assay | Same - symptomatic patients | | Assay Targets | Influenza A Virus, Influenza B Virus, and RSV viral RNA | Influenza A, influenza B, and influenza A, subtype 2009 H1N1 | Same as Xpert Flu/RSV XC Assay | | Specimen Types | Nasal aspirate/wash (NA/W) specimens and Nasopharyngeal (NP) swab specimens | Same as Xpert Flu/RSV XC Assay | Nasopharyngeal (NP) swab specimens; use of ProFlu+ Assay with NA/W specimens was validated. | | Similarities | | | | | | Device | Predicate Devices | | | Item | Cepheid Xpert Flu/RSV XC | Current Cepheid Xpert Flu | Hologic Prodesse ProFlu+ Assay…