What is the FDA product code for cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

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

What is the regulatory pathway for cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

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

Who can help prepare an FDA 510(k) submission like cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

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.

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

Q: Who is the manufacturer of cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

Roche Molecular Systems, Inc. filed the 510(k) submission for cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822).

K213822 · Roche Molecular Systems, Inc. · OCC · Jul 6, 2022 · Microbiology

Device Facts

Record ID	K213822
Device Name	cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Applicant	Roche Molecular Systems, Inc.
Product Code	OCC · Microbiology
Decision Date	Jul 6, 2022
Decision	SESE
Submission Type	Special
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 is a multiplex real-time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection. The test is intended for use as an aid in the diagnosis of influenza A, influenza B, and RSV infections in humans in conjunction with clinical and epidemiological risk factors. The test is intended for use on the cobas Liat System.

Device Story

Multiplex real-time RT-PCR assay; detects/differentiates influenza A, influenza B, and RSV RNA in nasopharyngeal swabs. Used on cobas Liat System; automated workflow. Modification: replacement of cobas Dilution UTM with Roche Negative Buffer (NEG BUF) for negative/positive control diluents. No impact on assay workflow or clinical specimen testing. Intended for clinical laboratory use to aid diagnosis of respiratory infections.

Clinical Evidence

No clinical data; bench testing only. Verification activities performed based on risk analysis to confirm functional equivalence of the new buffer material.

Technological Characteristics

Multiplex real-time RT-PCR assay. Instrumentation: cobas Liat System. Modification: substitution of cobas Dilution UTM with Roche Negative Buffer (NEG BUF) for control diluents. Fundamental technology unchanged.

Indications for Use

Indicated for patients with signs and symptoms of respiratory infection to aid in the differential diagnosis of Influenza A, Influenza B, and RSV. Not intended to detect Influenza C.

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 Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822 - original clearance)

Related Devices

K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System · Roche Molecular Systems, Inc. · Feb 16, 2021
K142045 — XPERT FLU/RSV XC ASSAY · Cepheid · Nov 22, 2014
K241573 — Alinity m Resp-4-Plex · Abbott Molecular, Inc. · Feb 14, 2025
K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack · Focus Diagnostics, Inc. · Sep 21, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Date: July 6, 2022 Image /page/0/Picture/1 description: The image contains 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. Roche Molecular Systems, Inc. Khushvanreep Singh Official Correspondent 4300 Hacienda Drive Pleasanton, California 94588-2722 Re: K213822 Trade/Device Name: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, OOI Dated: December 7, 2021 Received: December 8, 2021 Dear Khushvanreep Singh: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213822 ### Device Name cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System ### Indications for Use (Describe) The cobas Influenza A/B & RSV Nucleic acid test for use on the cobas 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 differential diagnosis 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 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/H/N1 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. Type of Use (*Select one or both, as applicable*) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | # 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}------------------------------------------------ # cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat® System 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. | Submitter Name | Roche Molecular Systems, Inc. | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 4300 Hacienda Drive Pleasanton, CA 94588-2722 | | Contact | Khushvanreep Singh Phone: (848) 250-4084 Email: khushvanreep.singh@roche.com | | Date Prepared | September 24, 2021 | | Proprietary Name | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | | Common Name | Influenza A, B, RSV Panel | | Classification Name | Respiratory viral panel multiplex nucleic acid assay Real Time Nucleic Acid Amplification System | | Product Codes | OCC, 21 CFR 866.3980 OOI, 21 CFR 862.2570 | | Predicate Devices | cobas® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System (K210234) | | Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ Establishment Number: 2243471 Roche Molecular Systems, Inc. Pleasanton, CA Establishment Number: 3004141078 | {4}------------------------------------------------ ### 1. DEVICE DESCRIPTION The cobas® Liat® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System (cobas® Influenza A/B & RSV) is an automated in vitro diagnostic test for the qualitative detection of Influenza A, Influenza B, and RSV RNA in nasopharyngeal swab (NPS) specimens. The sample-to-result time is ~20 minutes. The assay is performed on the Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using realtime RT-PCR assays. The assay targets a well-conserved region of the matrix gene of Influenza A (Inf A target), the non-structure 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 virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR reactions. The System consists of an instrument and preloaded software for running tests and viewing the results. The system requires the use of a single-use disposable cobas® Influenza A/B & RSV assay tube that holds the nucleic acid purification and RT-PCR reagents, and hosts the sample preparation and RT-PCR processes. The detection module monitors the reaction in real-time, while an on-board computer analyzes the collected data and outputs an interpreted result. The latter is displayed in the assay report on the integrated LCD touch screen of the cobas® Liat® Analyzer and in an electronic file. The report can be printed directly through a USB or network-connected printer. The results can also be exported to an external server, middleware or data management system, or to a Laboratory Information System (LIS). ### Test Workflow 1.1. Nasopharyngeal swab can be collected following the user institution's standard procedures. For nasopharyngeal swab samples suspended in collection media, a user transfers the sample into cobas® Influenza A/B & RSV assay tube. A user then scans the assay tube barcode to identify the test and scans the sample barcode to code the sample ID using the cobas® Liat® System. The assay tube is then inserted into the cobas® Liat® Analyzer (Figure 1). The analyzer performs all test steps and outputs interpreted results in approximately 20 minutes. A report of the interpreted results can be viewed in the View Results window, and printed directly through a USB connected printer. {5}------------------------------------------------ # Figure 1: Illustration of cobas® Liat® Analyzer Assay Testing Process Image /page/5/Picture/1 description: The image shows three different steps of a medical process. In each step, a gloved hand is interacting with a medical device. The device has a screen and buttons, and in each step, the hand is either inserting a vial or tube into the device or holding it nearby. #### 2. INTENDED USE The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System (cobas® 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 differential diagnosis 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 BSL3+ facility is available to receive and culture specimens. {6}------------------------------------------------ ### TECHNOLOGICAL CHARACTERISTICS 3. The technological characteristics and intended use of cobas® Influenza A/B & RSV for use on the cobas® Liat® System, when used with cobas® Influenza A/B & RSV Assay Script v1.16 has not changed from the predicate device. Table 1 provides a comparison of the modified device to the predicate device, as cleared through K210234. {7}------------------------------------------------ | | | | Table 1: Comparison of the cobas® Influenza A/B & RSV Assay with cobas® Influenza A/B & RSV Assay Script to the Predicate Device | |-----------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | | | | | | Item Name | Submitted Device: cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | Predicate Device: K210234 cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | | | Intended Use | Same | The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System (cobas® 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 differential diagnosis 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 BSL3+ facility is available to receive and culture specimens. | | | Regulation | Same | 21 CFR 866.3980 | | | Product Code | Same | OCC, OOI | | | Assay Target | Same | Influenza A, Influenza B, RSV | | | Sample Type | Same | Nasopharyngeal Swab | | | Internal Control | Same | Yes for sample preparation and RT-PCR performance using encapsulated RNA | | | Influenza A Viral Target | Same | Well conserved region of the matrix gene | | | Item Name | Submitted Device: cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | Predicate Device: K210234 cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | | | Influenza B Viral Target | Same | Well conserved region of the non-structural protein (NSP) gene | | | RSV Viral Target | Same | Well conserved region of the matrix (M) gene | | | Assay Instrument | Same | cobas® Liat® Analyzer | | | CORE Software | Same | cobas® Liat® Analyzer Core Software 3.3 (K200065) | | | Assay Script (FRTA) | Same | 1.16 (K210234) | | | Self-contained System | Same | Yes, Integrated PC, software, and touch-screen display | | | All Assay Reagents Contained in Disposable | Same | Yes, no manual reagent addition required | | | Sample Volume Detection | Same | Yes, automatically checks that input sample volume exceeds lower limit | | | Automated Assay | Same | Yes, sample preparation, amplification and result interpretation | | | Error Diagnostic System | Same | Yes, monitors and records system parameters for error recover or abort if unrecoverable | | | Extraction Method | Same | Silica-magnetic bead-based nucleic acid extraction | | | Assay Method | Same | RT-PCR for detecting the presence/absence of viral RNA in clinical specimens | | | Detection Technique | Same | Multiplex assay using different reporter dyes for each target | | | Result Interpretation | Same | Automated | | | PCR Curve Pattern Recognition | Same | Yes, ensures abnormal PCR curves are called "Invalid" or "Indeterminate" | | | Assay Result | Same | Qualitative | | | Item Name | Submitted Device: cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | Predicate Device: K210234 cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV | | | User | Same | CLIA Waived (CW1500018) | | | Test Availability | Same | Random access, on-demand test | | | Time-to-result | Same | ~20 minutes | | | Limit of Detection | Same | 10-3 – 10-1 TCID50/mL | | | Reactivity | Same | Reactive against 28 Flu A, 15 Flu B, and 7 RSV strains tested | | | Cross Reactivity | Same | 35 microorganisms and human genomic DNA tested. No cross reactivity found. | | | Interfering Microorganisms | Same | 35 microorganisms and human genomic DNA tested. No effect on detection found. | | | Interfering Substances | Same | 10 substances tested. No effect on detection found. | | | Reproducibility | Same | ≥99.8% total percent agreement | | | Negative Control Buffer | Roche Negative Buffer (NEG BUF) comprised of Generic Specimen Diluent (GSD) | Dilution Universal Transport Media (UTM) | | | Positive Control Diluent | Roche Negative Buffer (NEG BUF) comprised of Generic Specimen Diluent (GSD) | Dilution Universal Transport Media (UTM) | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### 4. DESCRIPTION OF CHANGE The negative control buffer and positive control diluent provided in the cobas® Influenza A/B & RSV Quality Control Kit will be changed from Dilution Universal Transport Media (UTM) to Roche Negative Buffer (NEG BUF). ### DESIGN AND DEVELOPMENT ACTIVITY SUMMARY 5. Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the cobas® Influenza A/B & RSV Quality Control Kit as part of cobas® Influenza A/B & RSV nucleic acid test for use on the cobas® Liat® System. RMD in Pleasanton coordinated the development and verification of cobas® Influenza A/B & RSV at the Product Requirements, Technical Requirements and Technical Requirement Specifications (Unit Specifications) level. These activities included risk management, requirements management, configuration management, and verification testing. ### ASSAY PERFORMANCE 6. Performance of the cobas® Influenza A/B & RSV assay when used with NEG BUF as a negative control and positive control diluent was assessed. It was determined that the overall cobas® Influenza A/B & RSV assay performance claims were not impacted by the changed control material when compared to the current commercially available version of the assay and quality control kit. The change is limited to the control processing and does not affect clinical specimen testing. ### 7. CONCLUSION Equivalent performance of the modified device and the current commercial device has been demonstrated, and therefore, it was concluded that the analytical and clinical performance of the product has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K210234 and CLIA waived through CW150018.