cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

K153544 · Iquum, Inc. · OCC · Jul 25, 2016 · Microbiology

Device Facts

• Record ID: K153544
• Device Name: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
• Applicant: Iquum, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Jul 25, 2016
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas® Liat Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the diagnosis and differentiation of influenza A, influenza B, and RSV in humans and is not intended to detect influenza C. 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. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Performance characteristics for influenza A were established during the 2013-2014 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other 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

The cobas Liat Influenza A/B & RSV assay is a rapid, automated, point-of-care diagnostic test. It accepts nasopharyngeal swab (NPS) specimens in viral transport media. The device uses a single-use, disposable cobas Liat Tube containing pre-packed reagents. The cobas Liat System integrates sample purification, nucleic acid extraction, and real-time RT-PCR amplification. The system uses mechanical actuators to compress tube segments, moving the sample through processing steps (lysis, binding, washing, elution, and amplification). An embedded microprocessor controls these processes. The system outputs qualitative results (Detected/Not Detected) for Influenza A, Influenza B, and RSV in approximately 20 minutes. It is intended for use by nurses and laboratory technologists in emergency rooms, urgent care, and outpatient clinics. The output is displayed on an LCD screen or printed, aiding clinicians in rapid diagnosis and patient management decisions, such as determining appropriate antiviral therapy or infection control measures.

Clinical Evidence

Clinical study evaluated 1,350 prospective and 292 retrospective NPS specimens across 12 CLIA-waived sites. Comparator was an FDA-cleared multiplex RT-PCR assay. Prospective positive agreement: 98.3% (Inf A), 95.2% (Inf B), 97.0% (RSV). Prospective negative agreement: 96.0% (Inf A), 99.4% (Inf B), 98.7% (RSV). Retrospective positive agreement: 98.7% (Inf A), 99.0% (Inf B), 98.8% (RSV). Retrospective negative agreement: 99.1% (Inf A), 99.5% (Inf B), 96.6% (RSV).

Technological Characteristics

Integrated, closed-system, point-of-care platform. Uses silica-magnetic bead-based nucleic acid extraction and TaqMan-probe based real-time RT-PCR. Targets: matrix gene (Inf A), non-structural protein gene (Inf B), matrix gene (RSV). Includes internal process control (encapsulated RNA). Single-use disposable tube with pre-packed reagents. Automated result interpretation via embedded microprocessor. No calibration required.

Indications for Use

Indicated for patients of all ages with signs and symptoms of respiratory infection to aid in the diagnosis and differentiation of influenza A, influenza B, and RSV. For prescription use only.

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

• cobas® Liat Influenza A/B (K11387)
• Hologic Prodesse ProFlu+™ (K073029, K081030, K092500, K110968, K132129)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them.

July 25, 2016

Public Health Service

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

IQuum, Inc. David W. Gates, Ph.D. Senior Director, Regulatory Affairs 4300 Hacienda Drive Pleasanton, CA 94588

Re: K153544

Trade/Device Name: cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas Liat Influenza A/B & RSV); cobas® Influenza A/B & RSV Quality Control Kit Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: II Product Code: OCC, OZE, OOI, JJX Dated: May 31, 2016 Received: June 1, 2016

Dear Dr. Gates:

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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

for 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) K153544

#### Device Name

1) cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas® Liat Influenza A/B & RSV); 2) cobas® Influenza A/B & RSV Quality Control Kit

#### Indications for Use (Describe)

- 1) The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas® Liat Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the diagnosis and differentiation of influenza B, and RSV in humans and is not intended to detect influenza C.
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. Conversely, positive results do not ruleout bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Performance characteristics for influenza A were established during the 2013-2014 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other 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.

- 2) The cobas® Influenza A/B & RSV Quality Control Kit contains External Controls for use with the cobas® Liat Influenza A/B & RSV assay. External Controls are run during the Add cobas® Liat Influenza A/B & RSV Tube Lot procedure. Additional External Controls should be tested in accordance with local, state, federal and/or accrediting organization requirements as applicable.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) SUMMARY

Summary Date: June 16, 2016

# A. 510(k) Number: K153544

# B. Purpose for Submission:

The purpose of this submission is to request 510k clearance of the cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas® Liat Influenza A/B & RSV) and the cobas® Influenza A/B & RSV Quality Control Kit.

# C. Measurand:

The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System is a rapid, automated in vitro diagnostic test for the qualitative detection of Influenza B and RSV RNA from nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory infection.

# D. Type of Test:

Multiplex nucleic acid assay for the qualitative detection of Influenza A, Influenza B and RSV RNA from NPS specimens, including nucleic acid isolation and multiplex real-time RT-PCR amplification using the cobas® Liat System.

# E. Applicant:

IQuum, Inc. (a wholly-owned subsidiary of Roche Molecular Systems Inc.) 700 Nickerson Road Marlborough, MA 01752 Tel: [phone] Fax: [phone]

Contact name: Lingjun Chen Title: Vice President, Point-of-care Operational Development Tel: [phone] Email: [e-mail]

# F. Proprietary and Established Names:

- 1) cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (cobas Liat Influenza A/B & RSV)
- 2) cobas® Influenza A/B & RSV Quality Control Kit

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# G. Regulatory Information:

- 1. Regulation section:
- 21 CFR 866.3980. Respiratory Viral Panel Multiplex Nucleic Acid Assay

2. Classification:

Class II

3. Product code:

OCC, OZE, OOI, JJX

4. Panel:

Microbiology (83)

# H. Intended Use:

- 1. Intended use(s):
- 1) The cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat System (cobas Liat Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the diagnosis and differentiation of influenza A, influenza B, and RSV in humans and is not intended to detect influenza C.

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. Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease.

Performance characteristics for influenza A were established during the 2013-2014 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other 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 BSL3+ facility is available to receive and culture specimens.

- 2) The cobas® Influenza A/B & RSV Quality Control Kit contains External Controls for use with the cobas ° Liat Influenza A/B & RSV assay. External Controls are run during the

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Add cobas "Liat Influenza A/B & RSV Tube Lot procedure. Additional External Controls should be tested in accordance with local, state, federal and/or accrediting organization requirements as applicable.

- 2. Indication(s) for use:
Same as Intended Use

- 3. Special conditions for use statement(s):
For prescription use only

- 4. Special instrument requirements:
Requires the cobas® Liat System

# I. Device Description:

The cobas Liat Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System ("cobas" Liat Influenza A/B & RSV assay") is a rapid, automated in vitro diagnostic test for the qualitative detection of influenza A, influenza B, and RSV RNA in nasopharyngeal swab (NPS) specimens eluted in viral transport media.

The assay targets a well-conserved region of the matrix gene of influenza A (Inf A target), the non-structural protein gene of influenza B (Inf B target), and the matrix gene of RSV (RSV target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target viruses and to monitor the presence of inhibitors in the sample preparation and RT-PCR.

The assay utilizes a single-use disposable cobas® Liat Tube that holds the sample purification and PCR reagents, and hosts the sample preparation and PCR processes. The cobas Liat Tube uses a flexible tube as a sample vessel. It contains all required unit dose reagents pre-packed in tube segments, separated by peelable seals, in the order of reagent use.

The cobas "Liat System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples. The cobas Liat System performs all assay steps from clinical sample and reports assay result automatically. During the testing process. multiple sample processing actuators of the cobas " Liat System compress the cobas" Liat Tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction volume, temperature, and time to conduct sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution and real-time PCR. An embedded microprocessor controls and coordinates the actions of these sample processors to perform all required assay processes within the closed cobas Liat Tube.

Positive and negative controls are provided in the cobas® Influenza A/B & RSV Quality Control Kit. The positive control comprises inactivated Influenza B and RSV virus in a dried format. The negative control comprises Universal Transport Media (UTM).

To perform the cobas Liat Influenza A/B & RSV assay, an operator first collects a nasopharyngeal swab and places the swab into UTM. The operator transfers the sample into cobas " Liat Influenza A/B & RSV assay tube using a transfer pipette, and scans the tube barcode to identify the test and the sample barcode to code the sample ID with the assay run on the

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cobas® Liat System. The cobas® Liat Tube is then inserted into the cobas® Liat System. The system performs all the test steps and outputs interpreted results (e.g. Influenza A Detected, Influenza B Not Detected, RSV Not Detected) in ~20 minutes. A report of the interpreted results can be viewed on the cobas " Liat System's LCD screen, and printed directly through a USB or network connected printer. No reagent preparation or additional steps are required other than adding the sample to the cobas Liat Tube. Because all the reagents are contained within the cobas Liat Tube and no sample or reagent needs to be removed from the tube, crosscontamination between samples is minimized.

The results are interpreted by the cobas Liat System software from measured fluorescent signals and real time curve recognition algorithm. All possible final test results are described below.

| Result Report | | Interpretation |
|------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Influenza<br>A | Influenza A Not<br>Detected | Negative test for Influenza A<br>(no Influenza A RNA detected) |
| | Influenza A Detected | Positive test for Influenza A<br>(Influenza A RNA present) |
| | Influenza A<br>Indeterminate.<br>Repeat Assay. | Presence or absence of Influenza A cannot be<br>determined. Repeat assay with same sample or, if<br>possible, new sample. |
| | Influenza B | Influenza B Not<br>Detected |
| Influenza B Detected | | Positive test for Influenza B<br>(Influenza B RNA present) |
| Influenza B<br>Indeterminate.<br>Repeat Assay. | | Presence or absence of Influenza B cannot be<br>determined. Repeat assay with same sample or, if<br>possible, new sample. |
| RSV | | RSV Not Detected |
| | RSV Detected | Positive test for RSV<br>(RSV RNA present) |
| | RSV Indeterminate.<br>Repeat Assay. | Presence or absence of RSV cannot be determined.<br>Repeat assay with same sample or, if possible, new<br>sample. |
| | | Assay Invalid. Repeat Assay |
| | [Error]. Assay Aborted | |

# Interpretation of Results

If the test result is "Indeterminate" or "Invalid", the assay should be repeated with the same patient specimen, or if possible, with a newly collected specimens that have repeat "Indeterminate" or "Invalid" results should be sent to a laboratory for confirmatory testing.

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If an assay is aborted due to run error, or if an assay is aborted by user, the test should be repeated with the same sample or, if possible, a new sample. Roche Service Representative should be contacted if repeat "Errors" are reported.

Dual infections of Influenza A and Influenza B are rare. If the test result is "Influenza A Detected" and "Influenza B Detected", the assay should be repeated with the same patient specimen, or if possible, with a newly collected specimens that have repeat "Influenza A Detected" and "Influenza B Detected" results should be sent to a laboratory for confirmatory testing.

# J. Substantial Equivalence Information:

- 1. Predicate device name(s):
Hologic Prodesse ProFlu+™

Roche cobas Influenza A/B Nucleic Acid Test for Use on the cobas Liat System

2. Predicate 510(k) number(s):

K073029, K081030, K092500, K110968, K132129

K11387

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# 3. Comparison with predicate:

| | Device: | Predicate: | Predicate: |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item Name | cobas® Liat Influenza A/B & RSV | cobas® Liat Influenza A/B | ProFlu+ |
| Intended Use | The cobas® Influenza A/B & RSV<br>Nucleic Acid Test for Use on the<br>cobas® Liat System is an automated<br>multiplex real-time RT-PCR assay<br>for the rapid <i>in vitro</i> qualitative<br>detection and discrimination of<br>influenza A virus, influenza B virus,<br>and respiratory syncytial virus<br>(RSV) RNA in nasopharyngeal swab<br>specimens from patients with signs<br>and symptoms of respiratory<br>infection in conjunction with clinical<br>and epidemiological risk factors.<br>The test is intended for use as an aid<br>in the diagnosis and differentiation<br>of influenza A, influenza B, and<br>RSV in humans and is not intended<br>to detect influenza C.<br>Negative results do not preclude<br>influenza virus or RSV infection and<br>should not be used as the sole basis<br>for treatment or other patient<br>management decisions. Conversely,<br>positive results do not rule-out<br>bacterial infection or co-infection<br>with other viruses. The agent<br>detected may not be the definite<br>cause of disease.<br>Performance characteristics for | The cobas® Influenza A/B Nucleic<br>Acid Test for Use on the cobas® Liat<br>System is an automated multiplex<br>real-time RT-PCR assay for the<br>rapid <i>in vitro</i> qualitative detection<br>and discrimination of influenza A<br>virus and influenza B virus RNA in<br>nasopharyngeal swab specimens<br>from patients with signs and<br>symptoms of respiratory infection in<br>conjunction with clinical and<br>epidemiological risk factors. The<br>test is intended for use as an aid in<br>the differential diagnosis of<br>influenza A and influenza B in<br>humans and is not intended to detect<br>influenza C.<br>Negative results do not preclude<br>influenza virus infection and should<br>not be used as the sole basis for<br>treatment or other patient<br>management decisions. Conversely,<br>positive results do not rule-out<br>bacterial infection or co-infection<br>with other viruses. The agent<br>detected may not be the definite<br>cause of disease.<br>Performance characteristics for<br>influenza A were established when | The ProFlu+ Assay is a multiplex<br>Real Time RT-PCR <i>in vitro</i><br>diagnostic test for the rapid and<br>qualitative detection and<br>discrimination of Influenza A Virus,<br>Influenza B Virus, and Respiratory<br>Syncytial Virus (RSV) nucleic acids<br>isolated and purified from<br>nasopharyngeal (NP) swab<br>specimens obtained from<br>symptomatic patients. This test is<br>intended for use to aid in the<br>differential diagnosis of Influenza A<br>Influenza B and RSV viral infections<br>in humans and is not intended to<br>detect Influenza C.<br>Negative results do not preclude<br>Influenza or RSV virus infection and<br>should not be used as the sole basis<br>for treatment or other management<br>decisions. Conversely, positive<br>results do not rule-out bacterial<br>infection or co-infection with other<br>viruses. The agent detected may not<br>be the definite cause of disease. The<br>use of additional laboratory testing<br>and clinical presentation must be<br>considered in order to obtain the<br>final diagnosis of respiratory viral |
| | Device: | Predicate: | Predicate: |
| Item Name | cobas® Liat Influenza A/B & RSV | cobas® Liat Influenza A/B | ProFlu+ |
| | influenza A were established during<br>the 2013-2014 and the 2014-2015<br>influenza seasons when influenza<br>A/H3 and A/H1N1 pandemic were<br>the predominant influenza A viruses<br>in circulation. When other influenza<br>A viruses are emerging, performance<br>characteristics may vary.<br>If infection with a novel influenza A<br>virus is suspected based on current<br>clinical and epidemiological<br>screening criteria recommended by<br>public health authorities, specimens<br>should be collected with appropriate<br>infection control precautions for<br>novel virulent influenza viruses and<br>sent to state or local health<br>department for testing. Viral culture<br>should not be attempted in these<br>cases unless a BSL3+ facility is<br>available to receive and culture<br>specimens. | influenza A/H1 and A/H3 were the<br>predominant influenza A viruses in<br>circulation. When other influenza A<br>viruses are emerging, performance<br>characteristics may vary.<br>If infection with a novel influenza A<br>virus is suspected based on current<br>clinical and epidemiological<br>screening criteria recommended by<br>public health authorities, specimens<br>should be collected with appropriate<br>infection control precautions for<br>novel virulent influenza viruses and<br>sent to state or local health<br>department for testing. Viral culture<br>should not be attempted in these<br>cases unless a BSL3+ facility is<br>available to receive and culture<br>specimens. | infection.<br>Performance characteristics for<br>Influenza A Virus were established<br>when Influenza A/H3 and A/H1<br>were the predominant Influenza A<br>viruses in circulation (2006-2007<br>respiratory season). Performance<br>characteristics for Influenza A were<br>confirmed when Influenza A/H1,<br>Influenza A/H3, and Influenza<br>A/2009 H1N1 were the predominant<br>Influenza A viruses in circulation<br>(2008 and 2009). When other<br>Influenza A viruses are emerging,<br>performance characteristics may<br>vary.<br>If infections with a novel Influenza<br>A virus is suspected based on current<br>clinical and epidemiological<br>screening criteria recommended by<br>public health authorities, specimens<br>should be collected with appropriate<br>infection control precautions for<br>novel virulent Influenza viruses and<br>sent to state or local health<br>department for testing. Viral culture<br>should not be attempted in these<br>cases unless a BSL3+ facility is<br>available to receive and culture<br>specimens. |
| Item Name | Device:<br>cobas® Liat Influenza A/B & RSV | Predicate:<br>cobas® Liat Influenza A/B | Predicate:<br>ProFlu+ |
| Regulation | 21 CFR 866.3980 | (same) | (same) |
| Product Code | OCC | (same) | (same) |
| Assay Target | Influenza A<br>Influenza B<br>RSV | Influenza A<br>Influenza B | Influenza A<br>Influenza B<br>RSV |
| Sample Type | Nasopharyngeal Swab | (same) | (same) |
| Internal Control | Yes for sample preparation and RT-<br>PCR performance using<br>encapsulated RNA | (same) | Yes for RT-PCR performance only<br>using <i>in vitro</i> transcribed RNA.<br>Extraction control is recommended<br>but not provided. |
| Influenza A Viral Target | Well conserved region of the matrix<br>gene | (same) | (same) |
| Influenza B Viral Target | Well conserved region of the non-<br>structural protein (NSP) gene | (same) | (same) |
| RSV Viral Target | Well conserved region of the matrix<br>(M) gene | N/A | Polymerase gene |
| Extraction Method | Integrated silica-magnetic bead-<br>based nucleic acid extraction | (same) | Silica-magnetic bead-based nucleic<br>acid extraction using Roche MagNA<br>Pure LC System, or bioMérieux<br>NucliSENS easyMag |
| Assay Method | RT-PCR for detecting the presence /<br>absence of viral RNA in clinical<br>specimens | (same) | (same) |
| Detection Technique | Multiplex assay using different<br>reporter dyes for each target | (same) | (same)…