(19 days)
Not Found
No
The description details a standard real-time RT-PCR assay with automated sample processing and data analysis. There is no mention of AI, ML, or any learning algorithms used in the data interpretation or result output. The analysis is based on pre-defined thresholds and algorithms for detecting target sequences and monitoring controls.
No.
This device is an in vitro diagnostic test designed to detect viral RNA, aiding in the diagnosis of respiratory infections, not a therapeutic device.
Yes
The "Intended Use" section explicitly states that the test "is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans."
No
The device description explicitly states that the system consists of an instrument (cobas® Liat® Analyzer) and a single-use disposable assay tube, in addition to the software. This indicates the device is a hardware and software system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for "rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens". The term "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" section also states that it is an "automated in vitro diagnostic test".
- Purpose: The device is designed to analyze biological samples (nasopharyngeal swabs) to provide information about a patient's health status (presence of Influenza A, B, or RSV RNA) to aid in diagnosis. This is the fundamental purpose of an IVD.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
OCC, OOI, OZE
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
CLIA Waived (CW150018)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Limit of Detection: 10-3 - 10-1 TCID50/mL
Reproducibility: ≥99.8% total percent agreement
Predicate Device(s)
cobas® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System (K200065)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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.
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.
| 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) |
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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 | Kaitlyn Hameister |
| Phone: (925) 368-0589 | |
| FAX: (925) 225-0207 | |
| Email: kaitlyn.hameister@roche.com | |
| Date Prepared | January 18, 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 (K200065) | |
| Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ |
| Establishment Number: 2243471 | |
| Roche Molecular Systems, Inc. Pleasanton, CA | |
| Establishment Number: 3004141078 |
DEVICE DESCRIPTION 1.
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.
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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).
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.
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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.
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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.
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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: K200065
cobas® 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 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 |
| Item Name | Submitted Device:
cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay
Script (FRTA) v1.16 | Predicate Device: K200065
cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script
(FRTA) v1.15 |
| Influenza A Viral
Target | Same | Well conserved region of the matrix gene |
| 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) | 1.16 | 1.15 |
| 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 |
| Item Name | Submitted Device:
cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay
Script (FRTA) v1.16 | Predicate Device: K200065
cobas® Influenza A/B & RSV w/ cobas® Influenza A/B & RSV Assay Script
(FRTA) v1.15 |
| PCR Curve
Pattern
Recognition | 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. |
| 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 |
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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.
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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.