Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

Q: Who is the manufacturer of Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV?

Cepheid filed the 510(k) submission for Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K180218).

Q: What is the FDA product code for Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV?

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

Q: What is the regulatory pathway for Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV?

510(k) clearance (submission type: Dual Track).

Q: What are the predicate devices for Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV?

Xpert® Flu+RSV Xpress Assay (K151226); Cepheid Xpert® Nasopharyngeal Sample Collection Kit for Viruses (K171552); Cepheid Xpert® Nasal Sample Collection Kit for Viruses (K171552).

Q: Who can help prepare an FDA FDA submission like Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV?

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

K180218 · Cepheid · OCC · Jul 24, 2018 · Microbiology

Device Facts

Record ID	K180218
Device Name	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Applicant	Cepheid
Product Code	OCC · Microbiology
Decision Date	Jul 24, 2018
Decision	SESE
Submission Type	Dual Track
Regulation	21 CFR 866.3980
Device Class	Class 2

Intended Use

The Cepheid Xpert® Xpress Flu/RSV 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 Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) 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 2016-2017 influenza season when influenza A/H3N2 and A/HINI pandemic were the predominant influenza A viruses in circulation. 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/RSV Assay is an automated, multiplex real-time RT-PCR test for qualitative detection and differentiation of influenza A, influenza B, and RSV viral RNA. Input consists of nasopharyngeal or nasal swab specimens collected in viral transport medium. The assay is performed on the GeneXpert Xpress System (GX-II or GX-IV models). The system uses self-contained, single-use cartridges to perform automated sample preparation, nucleic acid extraction, and real-time RT-PCR amplification. The system includes internal controls (Sample Processing Control and Probe Check Control) to verify extraction, reagent rehydration, and probe integrity. Results are generated in approximately 30 minutes. The device is intended for use by healthcare providers as an aid in diagnosis. It provides rapid, actionable results to assist in clinical decision-making and patient management, potentially reducing time to diagnosis and improving infection control.

Clinical Evidence

Clinical performance was evaluated in a multi-center study (n=3265 for Flu, n=3103 for RSV) comparing the Xpert Xpress Flu/RSV Assay to an FDA-cleared molecular comparator. For NS specimens, PPA/NPA were 98.9%/97.5% (Flu A), 98.4%/99.3% (Flu B), and 98.2%/99.1% (RSV). For NP specimens, PPA/NPA were 97.6%/98.2% (Flu A), 97.3%/99.6% (Flu B), and 98.2%/98.5% (RSV). Overall assay success rate was 99.6%. Reproducibility was confirmed across three sites with high agreement.

Technological Characteristics

Multiplex real-time RT-PCR assay. Uses GeneXpert Xpress System (GX-II/GX-IV) with I-core technology. Cartridge-based, self-contained, automated sample preparation and extraction. Targets: Influenza A (MP, PB2, PA), Influenza B (MP, NS1, NS2), RSV A/B (Nucleocapsid). Internal controls: Sample Processing Control (SPC) and Probe Check Control (PCC). Connectivity: Standalone instrument. Sterilization: Not specified (single-use cartridge).

Indications for Use

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

Xpert® Flu+RSV Xpress Assay (K151226)
Cepheid Xpert® Nasopharyngeal Sample Collection Kit for Viruses (K171552)
Cepheid Xpert® Nasal Sample Collection Kit for Viruses (K171552)

Related Devices

K151226 — Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) · Cepheid · Dec 3, 2015
K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV · Cepheid · Dec 19, 2017
K162456 — 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 · Cepheid · Feb 13, 2017
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
K181289 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System · Cepheid · Aug 15, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 24, 2018 Cepheid Jim Kelly, Ph.D. Executive Director, Regulatory Affairs 904 Caribbean Drive Sunnyvale, California 94089 #### Re: K180218 Trade/Device Name: Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OCC, OOI, JSM Dated: January 24, 2018 Received: January 25, 2018 ## Dear Jim 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 Part 801 and Part 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 {1}------------------------------------------------ Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. #### Steven R. Gitterman -S for Uwe Scherf, Ph.D. 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) K180218 Device Name Cepheid Xpert® Xpress Flu/RSV Assay Indications for Use (Describe) Device Intended Use: The Cepheid Xpert® Xpress Flu/RSV 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 B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Xpress Flul RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) 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 and should not be used as for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza A/ H3N2 and A/HINI pandemic were the predominant influenza A viruses in circulation. 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 Nasopharyngeal Swab Specimen Collection Kit for Viruses: 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. Ancillary Nasal Swab Specimen Collection Kit for Viruses: The Xpert® Nasal Sample Collection Kit is designed to collect, preserve, and transport nasal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Xpress Flu/RSV Assay and the Xpert Xpress Flu Assay. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ #### 8.0 510(k) Summary As required by 21 CFR Section 807.92(c). | Submitted by: | Cepheid 904 Caribbean Drive Sunnyvale, CA 90489 Phone number: (408) 400-6838 | |-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Yi-Ping Lin, PhD | | Date of Preparation: | May 18, 2018 | | Device: | | | Trade name: | Xpert® Xpress Flu/RSV | | Common name: | Xpert Xpress Flu/RSV 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 (RSV) viral RNA | | 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: Xpert® Flu+RSV Xpress Assay [510(k) #K151226] | | | 2) For the Sample Collection Kits: Cepheid Xpert® Nasopharyngeal Sample Collection Kit for Viruses[510(k) # K171552] | | | Cepheid Xpert® Nasal Sample Collection Kit for Viruses [510(k) # K171552] | {5}------------------------------------------------ #### 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 and nasal swab (NS) specimens. The assay is performed on the Cepheid GeneXpert® Xpress System. The Xpert Xpress Flu/RSV Assay includes reagents for the detection and differentiation of influenza A, influenza B, and RSV viral RNA directly from NP swab and NS specimens from patients with signs and symptoms of respiratory tract infection. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are internal controls utilized by the GeneXpert Xpress System platform. The SPC is present to control for an adequate extraction and processing of the target sequences and to monitor for the presence of inhibitor in the PCR reaction. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The specimens are collected in viral transport medium and transported to the GeneXpert Xpress 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 Xpress 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. {6}------------------------------------------------ #### Device Intended Use: The Cepheid Xpert® Xpress Flu/RSV 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 Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) 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 2016-2017 influenza season when influenza A/H3N2 and A/HINI pandemic were the predominant influenza A viruses in circulation. 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 Nasopharyngeal Swab Specimen Collection Kit for Viruses 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 {7}------------------------------------------------ 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. #### Ancillary Nasal Swab Specimen Collection Kit for Viruses The Xpert® Nasal Sample Collection Kit is designed to collect, preserve, and transport nasal swab specimens containing viruses from patients with signs and symptoms of respiratory infection prior to analysis with the Xpert Xpress Flu/RSV Assay and the Xpert Xpress Flu Assay. #### Substantial Equivalence: The Xpert Xpress Flu/RSV Assay is substantially equivalent to the current Xpert® Flu+RSV Xpress Assay [510(k) #K151226]. The Xpert Xpress Flu/RSV Assay detects influenza A, influenza B, and RSV from nasopharyngeal (NP) swab and nasal swab (NS) specimens and the Xpert® Flu+RSV Xpress Assay detects 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 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. The data were used to determine the performance characteristics of the Xpert Xpress Flu/RSV Assay relative to the reference test. The reference test was FDA cleared for testing for Flu with NP swab and NS specimens and for testing for RSV with NP swab specimens. For these studies the reference test was also validated for testing for RSV with NS specimens. The study results showed that the Xpert Xpress Fly/RSV Assay is acceptable for its intended use and 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 device. {8}------------------------------------------------ | Similarities | | | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device | Predicate | | Item | Cepheid Xpert® Xpress Flu/RSV | Cepheid Xpert® Flu+RSV Xpress Assay 510(k)# K151226 | | Regulation | 866.3980 | Same | | Product Code | OCC, OOI | Same | | Device Class | II | Same | | Technology Principle of Operation | Multiplex real time RT-PCR | Same | | Similarities | | | | | Device | Predicate | | Item | Cepheid Xpert® Xpress Flu/RSV | Cepheid Xpert® Flu+RSV Xpress Assay 510(k)# K151226 | | Intended Use | The Cepheid Xpert® Xpress Flu/RSV 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 Xpress Flu/RSV Assay uses nasopharyngeal (NP) swab and nasal swab (NS) 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 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 2016- | 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 | | Similarities | | | | | Device | Predicate | | Item | Cepheid Xpert® Xpress Flu/RSV | Cepheid Xpert® Flu+RSV Xpress Assay 510(k)# K151226 | | | 2017 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. | 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. | | Indication 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 Xpress System | Same | | Similarities | | | | Item | Device Cepheid Xpert® Xpress Flu/RSV | Predicate Cepheid Xpert® Flu+RSV Xpress Assay 510(k)# K151226 | | Assay Results | Qualitative | Same | | Instrument System | Cepheid GeneXpert Xpress System (instrument model GX-II and GX-IV); Cepheid I-core technology | Cepheid GeneXpert Xpress System (instrument model GX-I); Cepheid I-core technology | | Primers and probes | Primers and probes to detect the presence of nucleic acid sequences of influenza A, influenza B, and RSV. | Same | | Laboratory Users | Untrained operators with no clinical lab experience. | Same | | Sample Preparation | Self-contained and automated after mixed specimen is added to cartridge. All other reagents are contained in the cartridge. | Same | | Primers and probes for influenza A, influenza B | Primers and probes to detect the presence of nucleic acid sequences of influenza A, influenza B, and RSV A/B. The Xpert Xpress Flu Assay contains primers and probes to detect additional RNA segments in order to protect the assay sensitivity and specificity from mutations in the influenza genome due to antigenic drifts and shifts. | Same | | Similarities | | | | | Device | Predicate…