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 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 BSL 3+ facility is available to receive and culture specimens.

Device Description

The cobas® 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 cobas® Liat® Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time 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 cobas® Liat® 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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the cobas® Influenza A/B & RSV Nucleic acid test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating that the modified device (cobas® Influenza A/B & RSV Assay Script v1.16) has equivalent performance to the predicate device (cobas® Influenza A/B & RSV Assay Script v1.15). Therefore, the acceptance criteria are largely implicitly tied to matching or maintaining the performance characteristics of the predicate device.

Performance Characteristic	Acceptance Criteria (from Predicate Device)	Reported Device Performance (Modified Device)
Intended Use	Same as predicate	Same as predicate
Regulation	Same as predicate	Same as predicate
Product Code	Same as predicate	Same as predicate
Assay Target	Same as predicate	Same as predicate
Sample Type	Same as predicate	Same as predicate
Internal Control	Yes, for sample prep and RT-PCR performance	Same as predicate
Influenza A Viral Target	Well-conserved region of matrix gene	Same as predicate
Influenza B Viral Target	Well-conserved region of non-structural protein (NSP) gene	Same as predicate
RSV Viral Target	Well-conserved region of matrix (M) gene	Same as predicate
Assay Instrument	cobas® Liat® Analyzer	Same as predicate
CORE Software	cobas® Liat® Analyzer Core Software 3.3 (K200065)	Same as predicate
Assay Script (FRTA)	1.15	1.16 (Modified)
Self-contained System	Yes	Same as predicate
All Assay Reagents Contained in Disposable	Yes	Same as predicate
Sample Volume Detection	Yes, automatic check	Same as predicate
Automated Assay	Yes, sample prep, amplification, interpretation	Same as predicate
Error Diagnostic System	Yes, monitors and records system parameters	Same as predicate
Extraction Method	Silica-magnetic bead-based nucleic acid extraction	Same as predicate
Assay Method	RT-PCR	Same as predicate
Detection Technique	Multiplex assay using different reporter dyes	Same as predicate
Result Interpretation	Automated	Same as predicate
PCR Curve Pattern Recognition	Yes	Same as predicate
Assay Result	Qualitative	Same as predicate
User	CLIA Waived (CW150018)	Same as predicate
Test Availability	Random access, on-demand test	Same as predicate
Time-to-result	~20 minutes	Same as predicate
Limit of Detection	10⁻³ - 10⁻¹ TCID50/mL	Same as predicate
Reactivity	Reactive against 28 Flu A, 15 Flu B, and 7 RSV strains	Same as predicate
Cross-Reactivity	No cross-reactivity with 35 microorganisms and human genomic DNA	Same as predicate
Interfering Microorganisms	No effect on detection due to 35 microorganisms and human genomic DNA	Same as predicate
Interfering Substances	No effect on detection due to 10 substances	Same as predicate
Reproducibility	≥99.8% total percent agreement	Same as predicate
Overall Assay Performance	Not Impacted by changes in v1.16 compared to v1.15	Not Impacted by changes in v1.16 compared to v1.15

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The test set included "multiple sample types" for each configuration of the assay script (v1.15 and v1.16). Specifically, these included negative controls, positive controls, negative specimens, and positive specimens containing co-formulated Influenza A, Influenza B, and RSV target material at a concentration of 3X the Limit of Detection (LoD). For the 3X LoD samples, mean Ct values were assessed.
Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted internally by Roche Molecular Diagnostics (RMD), Pleasanton, CA. It is a retrospective study in the sense that it compares a modified version of the software (v1.16) against a previously cleared version (v1.15) using defined sample types, rather than collecting new clinical samples from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This study is an analytical performance assessment comparing a software version against a previous version, not a clinical study involving diagnosis by experts. The "ground truth" for the test set specimens (e.g., negative controls, positive controls, 3X LoD samples) would have been established by the manufacturer's internal quality control and characterization processes.

4. Adjudication Method for the Test Set

Not applicable, as this was an analytical comparison study of software versions, not a clinical trial requiring adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was not a multi-reader, multi-case comparative effectiveness study. It was a technical comparison of an updated software algorithm (Assay Script v1.16) against a previous version (v1.15) for an existing in vitro diagnostic device. Therefore, there's no mention of human readers or improved performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance assessment of the updated algorithm. The cobas® Liat® System is an automated system that outputs an interpreted result directly (qualitative detection of viral RNA). The study assessed the impact of the algorithm change on these automated results.

7. The Type of Ground Truth Used

The ground truth for the test set samples used in this study was based on:

Defined characteristics of controls: Negative controls and positive controls have known compositions.
Spiked samples: Positive specimens containing co-formulated target material at a known concentration (3X LoD) were used, allowing for a quantitative ground truth for viral load.

8. The Sample Size for the Training Set

The document does not provide information about a training set. The changes implemented were to an "Algorithm parameter" and "Correction of defects (bug fixes)" in the assay script. This suggests the changes were based on identifying and addressing specific performance characteristics or issues with the original algorithm, rather than a re-training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a discrete "training set" in the context of machine learning model development is not mentioned or implied by the description of the software changes. The algorithm modifications were likely based on internal engineering analysis and optimization to address specific performance aspects (like tolerating early Cts) or bug fixes within the existing RT-PCR assay interpretation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an abstract design with three human profiles and a caduceus-like symbol. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

February 16, 2021

Roche Molecular Systems, Inc. Kaitlyn Hameister Senior Regulatory Affairs Specialist I 4300 Hacienda Drive Pleasanton, California 94588-2722

Re: K210234

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, OZE Dated: January 26, 2021 Received: January 28, 2021

Dear Kaitlyn Hameister:

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

{1}------------------------------------------------

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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-reportingcombination-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,

Maria Ines Garcia, Ph.D. Branch Chief 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) K210234

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 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.

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.

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 DrivePleasanton, CA 94588-2722
Contact	Kaitlyn HameisterPhone: (925) 368-0589FAX: (925) 225-0207Email: kaitlyn.hameister@roche.com
Date Prepared	January 18, 2021
Proprietary Name	cobas® Influenza A/B & RSV Nucleic acid test for use on thecobas® Liat® System
Common Name	Influenza A, B, RSV Panel
Classification Name	Respiratory viral panel multiplex nucleic acid assayReal Time Nucleic Acid Amplification System
Product Codes	OCC, 21 CFR 866.3980OOI, 21 CFR 862.2570
Predicate Devices	cobas® Influenza A/B & RSV Nucleic Acid Test for use on thecobas® Liat® System (K200065)
Establishment Registration	Roche Molecular Systems, Inc. Branchburg, NJEstablishment Number: 2243471Roche Molecular Systems, Inc. Pleasanton, CAEstablishment Number: 3004141078

DEVICE DESCRIPTION 1.

{4}------------------------------------------------

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 test being performed. In the first image, a gloved hand is holding a blue test tube with a swab inside, next to a machine with a screen. The second image shows a gloved hand inserting the blue test tube into the machine. The third image shows a gloved hand placing a clear test tube into the machine.

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 K200065.

{7}------------------------------------------------

Comparison of the cobas® Influenza A/B & RSV Assay with cobas® Influenza A/B & RSV Assay Script v1.16 to the Predicate Table 1: Device

Item Name	Submitted Device:cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script (FRTA) v1.16	Predicate Device: K200065cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script (FRTA) v1.15
Intended Use	Same	The cobas® Influenza A/B & RSV Nucleic acid test for use on thecobas® 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 ofInfluenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA innasopharyngeal swab specimens from patients with signs and symptoms ofrespiratory infection in conjunction with clinical and epidemiological risk factors. Thetest is intended for use as an aid in the differential diagnosis of Influenza A, InfluenzaB, 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 beused as the sole basis for treatment or other patient management decisions.Conversely, positive results do not rule out bacterial infection or co-infection withother viruses. The agent detected may not be the definite cause of disease.Performance characteristics for Influenza A were established during the 2013-2014and the 2014-2015 influenza seasons when Influenza A/H3 and A/H1N1 pandemicwere the predominant Influenza A viruses in circulation. When other Influenza Aviruses are emerging, performance characteristics may vary.If infection with a novel Influenza A virus is suspected based on current clinical andepidemiological screening criteria recommended by public health authorities,specimens should be collected with appropriate infection control precautions fornovel virulent Influenza viruses and sent to state or local health department fortesting. Viral culture should not be attempted in these cases unless a BSL3+ facility isavailable 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
Item Name	Submitted Device:cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV AssayScript (FRTA) v1.16	Predicate Device: K200065cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script(FRTA) v1.15
Influenza A ViralTarget	Same	Well conserved region of the matrix gene
Influenza B ViralTarget	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)	1.16	1.15
Self-containedSystem	Same	Yes, Integrated PC, software, and touch-screen display
All AssayReagentsContained inDisposable	Same	Yes, no manual reagent addition required
Sample VolumeDetection	Same	Yes, automatically checks that input sample volume exceeds lower limit
Automated Assay	Same	Yes, sample preparation, amplification and result interpretation
Error DiagnosticSystem	Same	Yes, monitors and records system parameters for error recover or abort ifunrecoverable
ExtractionMethod	Same	Silica-magnetic bead-based nucleic acid extraction
Assay Method	Same	RT-PCR for detecting the presence/absence of viral RNA in clinical specimens
DetectionTechnique	Same	Multiplex assay using different reporter dyes for each target
ResultInterpretation	Same	Automated
Item Name	Submitted Device:cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV AssayScript (FRTA) v1.16	Predicate Device: K200065cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script(FRTA) v1.15
PCR CurvePatternRecognition	Same	Yes, ensures abnormal PCR curves are called "Invalid" or "Indeterminate"
Assay Result	Same	Qualitative
User	CLIA Waived (CW150018)	CLIA Waived (CW150018)
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.
InterferingMicroorganisms	Same	35 microorganisms and human genomic DNA tested. No effect on detection found.
InterferingSubstances	Same	10 substances tested. No effect on detection found.
Reproducibility	Same	≥99.8% total percent agreement

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

4. DESCRIPTION OF CHANGE

cobas® Influenza A/B & RSV Assay Script v1.16 incorporates the following changes:

· Algorithm parameter changed for Influenza A and Influenza B targets to tolerate early Cts previously interpreted as invalid results.
Correction of defects (bug fixes). .

DESIGN AND DEVELOPMENT ACTIVITY SUMMARY 5.

Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the script software component of the cobas® Liat® System. RMD in Pleasanton coordinated the development and verification of cobas® Influenza A/B & RSV Assay Script v1.16 at the Product Requirements, Technical Requirements and Technical Requirement Specifications (Unit Specifications) level. These activities included risk management, requirements management, configuration management, verification testing, and regression analysis.

ASSAY PERFORMANCE 6.

Performance of the cobas® Influenza A/B & RSV assay with cobas® Influenza A/B & RSV Assay Script v1.16 was assessed by testing multiple sample types on both the predicate configuration (cobas® Influenza A/B & RSV Assay Script v1.15) and the modified configuration (cobas® Influenza A/B & RSV Assay Script v1.16). These sample types included negative controls, positive controls, negative specimens, and positive specimens containing co-formulated Influenza A, Influenza B, and RSV target material at a concentration of 3X the Limit of Detection (LoD). For each configuration (cobas® Influenza A/B & RSV Assay Script v1.15 and v1.16), each sample type was run on nine (9) cobas® Liat ® analyzers, and the assay run results for each configuration were compared and assessed for equivalency, based on the result output (for negative controls, positive controls, and negative samples) and mean Ct value (for 3X LoD samples). The results of this testing determined that the overall cobas® Influenza A/B & RSV assay performance claims were not impacted by changes implemented in cobas® Influenza A/B & RSV Assay Script v1.16, when compared to the current commercially available version of the assay script v1.15.

{11}------------------------------------------------

CONCLUSION 7.

Equivalent performance of the modified device and the current commercial device has been demonstrated, and analytical and clinical performance has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K200065 and CLIA waived through CW150018.

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
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.
(b)
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.