(28 days)
Not Found
No
The summary describes a real-time RT-PCR assay and system that automates sample processing and detection. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned is for running tests and viewing results, not for complex data analysis or pattern recognition typically associated with AI/ML in diagnostics.
No
The device is described as an in vitro diagnostic test for the rapid qualitative detection and discrimination of viruses and bacteria, intended as an aid in differential diagnosis. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the various tests performed by the device (cobas® Influenza A/B, cobas® Influenza A/B & RSV, and cobas® Strep A) are "intended for use as an aid in the differential diagnosis" of specific infections. The "Device Description" also describes them as "in vitro diagnostic test[s]".
No
The device description explicitly states that the system consists of an instrument (the cobas® Liat® Analyzer) and single-use disposable assay tubes, in addition to the software. This indicates a hardware component is essential to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the tests are "rapid in vitro qualitative detection and discrimination" of various pathogens (Influenza A/B, RSV, Strep A) in human specimens (nasopharyngeal swabs, throat swabs). The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description of each test clearly states that it is an "automated in vitro diagnostic test".
- Intended User/Care Setting: The tests are intended for "professional use in a clinical laboratory setting or point-of care (POC) location," which is a typical setting for IVDs.
- Predicate Devices: The document lists predicate devices with K numbers, which are associated with FDA clearances for medical devices, including IVDs. The names of the predicate devices also include "Nucleic Acid Test for use on the cobas® Liat® System," further indicating their nature as diagnostic tests.
The entire context of the document, including the description of the technology (RT-PCR, nucleic acid purification), the type of specimens used, and the purpose of the tests (aid in differential diagnosis), all point to these devices being In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® Influenza A/B) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus 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 and Influenza B in humans and is not intended to detect Influenza C.
Negative results do not preclude Influenza virus 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 when Influenza A/H1 and A/H3 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.
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.
The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.
The cobas® Strep A Nucleic acid test for use on the cobas® Liat® System is intended for professional use in a clinical laboratory setting or point-of care (POC) location.
Product codes (comma separated list FDA assigned to the subject device)
OCC, OZE, PGX, OOI
Device Description
The cobas® Influenza A/B Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of Influenza type A and type B viral RNA. The assay is performed on the cobas® Liat® System. The system automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time RT-PCR assays. The cobas® Liat® Analyzer consists of an instrument and preloaded software for running tests and viewing the results. The cobas® Liat® System consists of the analyzer and a single-use disposable cobas® Influenza A/B assay tube that holds the sample purification and RT-PCR reagents and hosts the sample preparation and RT-PCR processes. Other than adding the sample to the cobas® Influenza A/B assay tube, no reagent preparation or additional steps are required. Because each cobas® Influenza A/B assay tube is self-contained, cross-contamination between samples is minimized. Turnaround time for a test is 20 minutes.
The cobas® Influenza A/B assay includes reagents for the detection and differentiation of Influenza A and B viral RNA in nasopharyngeal swab (NPS) specimens in universal transport media (UTM) from patients suspected of having Influenza. The assay targets a well-conserved region of the matrix gene of Influenza A viral RNA (Inf A target) and non-structural protein (NS) gene of Influenza B (Inf B target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target viruses through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR reactions.
The cobas® Influenza A/B assay tube uses a flexible tube as a sample processing vessel. It contains all requisite PCR reagents pre-packed in assay tube segments separated by breakable seals. When a cobas® Influenza A/B assay tube containing a raw biological sample is inserted into the cobas® Liat® Analyzer, multiple sample processing actuators in the cobas® Liat Analyzer compress the cobas® Influenza A/B assay tube to selectively release the reagents, moving the sample from one segment to the next, and controlling reaction conditions. An embedded microprocessor controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target concentration enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Influenza A/B assay tube, minimizing cross-contamination between samples.
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).
The cobas® Liat® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System is an automated in vitro diagnostic test for the qualitative detection of 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 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).
The cobas® Strep Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes (Group A B -hemolytic Streptococcus, Strep A) DNA in throat swab specimens in Amies media.
The assay utilizes silica magnetic bead-based nucleic acid extraction, and TagMan probe-based real-time PCR amplification and detection. The assay targets a well-conserved region of the spy1258 gene of Strep A. An Internal Process Control (IPC) is also included. The IC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the sample preparation and PCR.
The cobas® Liat® System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Strep A assay tube, no reagent preparation or additional steps are required.
The system consists of an instrument with integrated software for running tests and analyzing the results. The system requires the use of a single-use disposable cobas® Strep A assay tube that holds all the sample purification and PCR reagents and hosts the sample preparation and PCR processes.
During the testing process, multiple sample processing actuators of the cobas® Liat® System compress the assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the nucleic acid test to achieve performance similar to or better than that of laboratory assays. An embedded microprocessor controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR.
All assay steps are performed within the closed and self-contained assay tube, minimizing crosscontamination between samples. The collected data is automatically analyzed and an interpreted result is output in the assay report on the integrated touch screen of the cobas® Liat® System. Turnaround time for this nucleic acid test is ~15 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal swab specimens
Throat swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) for all listed devices.
CLIA Waived (CW150003) for cobas® Influenza A/B Nucleic Acid Test for use on the cobas® Liat® System.
CLIA Waived (CW150018) for cobas® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System.
CLIA Waived (CW140014) for cobas® Strep A Nucleic Acid Test for use on the cobas® Liat® System.
Clinical laboratory setting or point-of care (POC) location for cobas® Strep A Nucleic Acid Test for use on the cobas® Liat® System.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the cobas® Influenza A/B assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
Performance of the cobas® Influenza A/B & RSV assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B & RSV assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
Performance of the cobas® Strep A assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Strep A assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
cobas® Influenza A/B & RSV Nucleic Acid Test for Use on the cobas® Liat® System:
Limit of Detection: $10^{-3} - 10^{-1}$ TCID50/mL
Reactivity: Reactive against 28 Flu A, 15 Flu B, and 7 RSV strains tested
Cross Reactivity: 35 microorganisms and human genomic DNA tested. No cross reactivity found.
Interfering Microorganisms: 35 microorganisms and human genomic DNA tested. No effect on detection found.
Interfering Substances: 10 substances tested. No effect on detection found.
Reproducibility: ≥99.8% total percent agreement
cobas® Strep A Nucleic Acid Test for Use on the cobas® Liat® System:
Limit of Detection: 100 – 101 CFU per test
Reactivity: Reactive against 9 Strep A strains tested
Cross Reactivity: 63 human pathogens tested, including 13 other Streptococcus species, 42 other bacteria, and 8 viruses. No cross reactivity found
Interfering Microorganisms: 63 human pathogens tested. No effect on detection
Interfering Substances: 28 substances at medically and/or physiologically relevant concentrations at near LOD. No effect on detection
Sensitivity: 98.5% (95% CI: 95.6% – 99.5%)
Specificity: 94.2% (95% CI: 91.6 - 96.1%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
February 10, 2020
Roche Molecular Systems, Inc. Kaitlyn Hameister Senior Regulatory Affairs Specialist I 4300 Hacienda Drive Pleasanton, California 94588-2722
Re: K200065
Trade/Device Name: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A 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, OZE, PGX, OOI Dated: January 13, 2020 Received: January 13, 2020
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 mediation-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,
Ribhi Shawar, Ph.D. (ABMM) Chief, General Bacteriology and Antimicrobial Susceptibility 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) K200065
RE 00.08
Device Name
The 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® 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.
Type of Use (Select one or both, as applicable) _ Over-The-Counter Use (21 CFR 801 Subpart C) X | Prescription Use (Part 21 CFR 801 Subpart D)
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
Indications for Use
510(k) Number (if known)
Device Name
cobas® Influenza A/B nucleic acid test for use on the cobas® Liat® System
Indications for Use (Describe)
The cobas® Influenza A/B Nucleic acid test for use on the cobas® Influenza A/B) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus 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 in humans and is not intended to detect Influenza C.
Negative results do not preclude Influenza virus 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 when Influenza A/H1 and A/H3 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)
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."
4
Indications for Use
510(k) Number (if known)
Device Name
cobas® Strep A nucleic acid test for use on the cobas® Liat® System
Indications for Use (Describe)
The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.
| 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 Druq 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."
5
cobas® Influenza A/B 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) 730-8813 | |
| FAX: (925) 225-0207 | |
| Email: kaitlyn.hameister@roche.com | |
| Date Prepared | December 20, 2019 |
| Proprietary Name | cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System |
| Common Name | Influenza A, B, 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 Nucleic Acid Test for use on the cobas® Liat® System |
| (K191729) | |
| Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ |
| Establishment Number: 2243471 | |
| Roche Molecular Systems, Inc. Pleasanton, CA | |
| Establishment Number: 3004141078 |
1. DEVICE DESCRIPTION
The cobas® Influenza A/B Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of Influenza type A and type B viral RNA. The assay is performed on the cobas® Liat® System. The system automates and integrates sample purification, nucleic acid amplification, and detection of the
6
target sequence in biological samples using real-time RT-PCR assays. The cobas® Liat® Analyzer consists of an instrument and preloaded software for running tests and viewing the results. The cobas® Liat® System consists of the analyzer and a single-use disposable cobas® Influenza A/B assay tube that holds the sample purification and RT-PCR reagents and hosts the sample preparation and RT-PCR processes. Other than adding the sample to the cobas® Influenza A/B assay tube, no reagent preparation or additional steps are required. Because each cobas® Influenza A/B assay tube is self-contained, cross-contamination between samples is minimized. Turnaround time for a test is 20 minutes.
The cobas® Influenza A/B assay includes reagents for the detection and differentiation of Influenza A and B viral RNA in nasopharyngeal swab (NPS) specimens in universal transport media (UTM) from patients suspected of having Influenza. The assay targets a well-conserved region of the matrix gene of Influenza A viral RNA (Inf A target) and non-structural protein (NS) gene of Influenza B (Inf B target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target viruses through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR reactions.
The cobas® Influenza A/B assay tube uses a flexible tube as a sample processing vessel. It contains all requisite PCR reagents pre-packed in assay tube segments separated by breakable seals. When a cobas® Influenza A/B assay tube containing a raw biological sample is inserted into the cobas® Liat® Analyzer, multiple sample processing actuators in the cobas® Liat Analyzer compress the cobas® Influenza A/B assay tube to selectively release the reagents, moving the sample from one segment to the next, and controlling reaction conditions. An embedded microprocessor controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target concentration enrichment, inhibitor removal, nucleic acid elution, and real-time PCR. All assay steps are performed within the closed and self-contained cobas® Influenza A/B assay tube, minimizing cross-contamination between samples.
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).
7
Test Workflow 1.1.
Nasopharyngeal swab can be collected following the user institution's standard procedures. For nasopharyngeal swab samples suspended in UTM, a user transfers the UTM sample into cobas® Influenza A/B 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. The analyzer performs all test steps and outputs interpreted results in 20 minutes. A report of the interpreted results can be viewed in the View Results window, and printed directly through a USB connected printer.
Figure 1: Illustration of cobas® Liat® Analyzer Assay Testing Process
Image /page/7/Picture/4 description: The image shows three different steps of a medical process. In the first image, a gloved hand is holding a blue medical container with a barcode on it, and a clear tube is being inserted into the container. The second image shows a gloved hand inserting the blue medical container into a machine with a screen. The third image shows a gloved hand inserting a clear tube into a machine with a screen that reads "20:00".
INTENDED USE 2.
The cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® Influenza A/B) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus 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 and Influenza B in humans and is not intended to detect Influenza C.
Negative results do not preclude Influenza virus 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.
8
Performance characteristics for Influenza A were established when Influenza A/H1 and A/H3 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.
9
3. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics and intended use of cobas® Liat® System, when used with oblas® Liat® Analyzer Software 3.3d are substantially equivalent to the legally marketed device, which was most recently cleared with cobas® Line Analyzer Software 3.2. Table 1 provides a comparison of the modified device to the predicate device, as cleared through K191729.
| Item Name | Submitted Device:
cobas® Influenza A/B w/ cobas® Liat® System Software 3.3 | Predicate Device: K191729
cobas® Influenza A/B w/ cobas® Liat® System Software 3.2 |
|--------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | The cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System
(cobas® Influenza A/B) is an automated multiplex real-time RT-PCR assay for the
rapid in vitro qualitative detection and discrimination of Influenza A virus and
Influenza B virus 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 and Influenza B in humans and is not intended to detect Influenza C.
Negative results do not preclude Influenza virus 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 when Influenza A/H1
and A/H3 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 |
| Regulation | Same | 21 CFR 866.3980 |
| Product Code | Same | OCC, OOI |
| Assay Target | Same | Influenza A, Influenza B |
| Item Name | Submitted Device:
cobas® Influenza A/B w/ cobas® Liat® System Software 3.3 | Predicate Device: K191729
cobas® Influenza A/B w/ cobas® Liat® System Software 3.2 |
| Sample Type | Same | Nasopharyngeal Swab |
| 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 |
| Assay Instrument | Same | cobas® Liat® Analyzer (Rebranded from Liat™ Analyzer) |
| Software | cobas® Liat® Analyzer Core Software 3.3
FABA 1.36 | cobas® Liat® Analyzer Core Software 3.2 (K191729)
FABA 1.35 |
| 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" |
| Item Name | Submitted Device:
cobas® Influenza A/B w/ cobas® Liat® System Software 3.3 | Predicate Device: K191729
cobas® Influenza A/B w/ cobas® Liat® System Software 3.2 |
| Assay Result | Same | Qualitative |
| User | CLIA Waived (CW150003) | CLIA Waived (CW150003) |
| Test Availability | Same | Random access, on-demand test |
| Time-to-result | Same | ~20 minutes |
Comparison of the cobas® Influenza A/B Assay with cobas® Liat® Analyzer Software 3.3 to the Predicate Device Table 1:
10
11
12
4. DESCRIPTION OF CHANGE: CORE SOFTWARE
cobas® Liat® Analyzer Software 3.3 incorporates the following changes:
- Operating System Migration to LINUX OS .
- Positive Patient ID .
- Translations (not applicable to US customers) .
- Enhanced Data Encryption .
- Thermal Printer Support .
- Generic Calculation Engine (not applicable to cleared assays) .
- Assay Masking .
- Integration of Advanced Tools .
- Correction of defects (bug fixes) .
5. DESIGN AND DEVELOPMENT ACTIVITY SUMMARY
Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the core software component of the cobas® Liat® System. The cobas® Liat® Analyzer core software was designed and developed by Roche Molecular Diagnostics in Rotkreuz, Switzerland.
RMD in Pleasanton and Rotkreuz coordinated the development and verification of cobas® Liat® Analyzer Software 3.3 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.
6. ASSAY PERFORMANCE
Performance of the cobas® Influenza A/B assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version.
13
CONCLUSION 7.
Equivalent performance of the modified device and the current commercial device has been demonstrated, and analytical or clinical performance has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K191729 and CLIA waived through CW150003.
14
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) 730-8813 | |
| FAX: (925) 225-0207 | |
| Email: kaitlyn.hameister@roche.com | |
| Date Prepared | December 20, 2019 |
| 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 (K153544) | |
| Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ |
| Establishment Number: 2243471 | |
| Roche Molecular Systems, Inc. Pleasanton, CA | |
| Establishment Number: 3004141078 |
1. DEVICE DESCRIPTION
The cobas® Liat® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System is an automated in vitro diagnostic test for the qualitative detection of Influenza B,
15
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 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 Universal Transport Media (UTM), a user transfers the UTM 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. The analyzer performs all test steps and outputs interpreted results in 20 minutes. A report of the interpreted results can be viewed in the View Results window, and printed directly through a USB connected printer.
16
Image /page/16/Figure/0 description: Figure 1 is an illustration of the cobas® Liat® Analyzer Assay Testing Process. The figure is a title for a document or presentation. The title is written in a clear, bold font.
Image /page/16/Picture/1 description: The image shows three different steps of a lab process. In the first image, a gloved hand is holding a blue container with a swab and barcode label next to a machine with a screen. The second image shows a gloved hand inserting the blue container into the machine. The third image shows a gloved hand placing a 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
17
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® Liat® Analyzer Software 3.3. Table 1 provides a comparison of the modified device to the predicate device, as originally cleared through K153544.
18
| Item Name | Submitted Device:
cobas® Influenza A/B & RSV w/ cobas® Liat® Analyzer Software 3.3 | Predicate Device: K153544
cobas® Influenza A/B & RSV w/ cobas® Liat® Analyzer Software 1.5.4 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 human
and is not intended to detect Influenza C.
Negative results do not preclude Influenza virus or RSV infection and should not be |
| | Same | 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. |
| | Same | 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. |
| | Same | 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 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® Liat® Analyzer Software 3.3 | Predicate Device: K153544
cobas® Influenza A/B & RSV w/ cobas® Liat® Analyzer Software 1.5.4 |
| 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 |
| Software | cobas® Liat® Analyzer Core Software 3.3
FRTA 1.15 | cobas® Liat® Analyzer Core Software 1.5.4 (K153544)
FRTA 1.13 |
| 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 |
| User | CLIA Waived (CW150018) | CLIA Waived (CW150018) |
| Item Name | Submitted Device:
cobas® Influenza A/B & RSV w/ cobas® Liat® Analyzer Software 3.3 | Predicate Device: K153544
cobas® Influenza A/B & RSV w/ cobas® Liat® Analyzer Software 1.5.4 |
| 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 |
Comparison of the cobas® Influenza A/B & RSV Assay with cobas® Liat® Analyzer Software 3.3 to the Predicate Device Table 1:
19
20
21
4. DESCRIPTION OF CHANGE: CORE SOFTWARE
cobas® Liat® System Software 3.3 incorporates the following changes:
- Operating System Migration to LINUX OS .
- Positive Patient ID .
- Translations (not applicable to US customers) .
- Enhanced Data Encryption .
- Thermal Printer Support .
- Generic Calculation Engine (not applicable to cleared assays) .
- Assay Masking .
- Integration of Advanced Tools .
- Correction of defects (bug fixes) .
5. DESIGN AND DEVELOPMENT ACTIVITY SUMMARY
Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the core software component of the cobas® Liat® System. The cobas® Liat® Analyzer core software was designed and developed by Roche Molecular Diagnostics in Rotkreuz, Switzerland.
RMD in Pleasanton and Rotkreuz coordinated the development and verification of cobas® Liat® Analyzer Software 3.3 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.
6. ASSAY PERFORMANCE
Performance of the cobas® Influenza A/B & RSV assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B & RSV assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version
22
CONCLUSION 7.
Equivalent performance of the modified device and the current commercial device has been demonstrated, and analytical or clinical performance has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K153544 and CLIA waived through CW150018.
23
cobas® Strep A 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) 730-8813 | |
| FAX: (925) 225-0207 | |
| Email: kaitlyn.hameister@roche.com | |
| Date Prepared | December 20, 2019 |
| Proprietary Name | cobas® Strep A Nucleic acid test for use on the cobas® Liat® System |
| Common Name | Strep A Test |
| Classification Name | Group A Streptococcus Nucleic Acid Amplification Assay System Real Time |
| Nucleic Acid Amplification System | |
| Product Codes | OYZ, 21 CFR 866.3470 |
| OOI, 21 CFR 862.2570 | |
| Predicate Devices | cobas® Strep A Nucleic Acid Test for use on the cobas® Liat® System |
| (K141338) | |
| Establishment Registration | Roche Molecular Systems, Inc. Branchburg, NJ |
| Establishment Number: 2243471 |
Roche Molecular Systems, Inc. Pleasanton, CA
Establishment Number: 3004141078 |
1. DEVICE DESCRIPTION
The cobas® Strep Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes
(Group A B -hemolytic Streptococcus, Strep A) DNA in throat swab specimens in Amies media.
24
The assay utilizes silica magnetic bead-based nucleic acid extraction, and TagMan probe-based real-time PCR amplification and detection. The assay targets a well-conserved region of the spy1258 gene of Strep A. An Internal Process Control (IPC) is also included. The IC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the sample preparation and PCR.
The cobas® Liat® System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Strep A assay tube, no reagent preparation or additional steps are required.
The system consists of an instrument with integrated software for running tests and analyzing the results. The system requires the use of a single-use disposable cobas® Strep A assay tube that holds all the sample purification and PCR reagents and hosts the sample preparation and PCR processes.
During the testing process, multiple sample processing actuators of the cobas® Liat® System compress the assay tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction conditions such as reaction volume, temperature, pressure, and incubation time. Precise control of all these parameters provides optimal conditions for assay reactions, allowing the nucleic acid test to achieve performance similar to or better than that of laboratory assays. An embedded microprocessor controls and coordinates these actions to perform all required assay processes, including sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution, and real-time PCR.
All assay steps are performed within the closed and self-contained assay tube, minimizing crosscontamination between samples. The collected data is automatically analyzed and an interpreted result is output in the assay report on the integrated touch screen of the cobas® Liat® System. Turnaround time for this nucleic acid test is ~15 minutes.
1.1. Test Workflow
Throat swab can be collected following the user institution's standard procedures. For throat swab samples suspended in Amies transport media, a user transfers the Amies sample into cobas® Strep 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
25
cobas® Liat® Analyzer. The analyzer performs all test steps and outputs interpreted results in ~15 minutes. A report of the interpreted results can be viewed in the View Results window, and printed directly through a USB connected printer.
Image /page/25/Figure/1 description: The image is a title for a figure. The title reads, "Figure 1: Illustration of cobas® Liat® Analyzer Assay Testing Process". The title is written in a bold, sans-serif font. The words "Figure 1" are slightly smaller than the rest of the title.
Image /page/25/Picture/2 description: The image shows three different steps of a lab process. In the first image, a gloved hand is holding a blue testing kit and inserting a swab into the kit. The second image shows the same testing kit being inserted into a machine with a digital display. The third image shows a gloved hand inserting a test tube into the same machine.
INTENDED USE 2.
The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A Bhemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pvogenes genome.
The cobas® Strep A Nucleic acid test for use on the cobas® Liat® System is intended for professional use in a clinical laboratory setting or point-of care (POC) location.
TECHNOLOGICAL CHARACTERISTICS 3.
The technological characteristics and intended use of cobas® Strep A for use on the cobas® Liat® System, when used with cobas® Liat® Analyzer Software 3.3, are substantially equivalent to the legally marketed device. Table 1 provides a comparison of the modified device to the predicate device, as originally cleared through K141338.
26
| Table 1: Comparison of the cobas Strep A for use with cobas® Liat® System Softare 3.3 with the Predicate Device (K141388) | ||
|---|---|---|
| Item Name | Submitted Device:
cobas® Strep A w/ cobas® Liat® Analyzer Software 3.3 | Predicate Device: K141338
cobas® Strep A w/ cobas® Liat® Analyzer Software 1.5.1 |
|-----------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | The cobas® Strep A nucleic acid test for use on the cobas® Liat® System
(cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of
Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat
swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain
reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment
of the Streptococcus pyogenes genome.
The cobas® Strep A Nucleic acid test for use on the cobas® Liat® System is intended
for professional use in a clinical laboratory setting or point- of - care (POC) location. |
| Regulation | Same | 21 CFR 866.3470 |
| Product Code | Same | OYZ, OOI |
| Assay Target | Same | Streptococcus A |
| Sample Type | Same | Throat Swab |
| Internal Control | Same | Yes |
| Strep Target | Same | Conserved sequence in transcription regulator gene of S. pyrogenes |
| Assay Instrument | Same | cobas® Liat® Analyzer (Rebranded from Liat™ Analyzer) |
| Software | cobas® Liat® Analyzer Core Software 3.3
SASA 1.28 | cobas® Liat® Analyzer Core Software 1.5.1 (K141338)
SASA 1.26 |
| 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 |
| Item Name | Submitted Device:
cobas® Strep A w/ cobas® Liat® Analyzer Software 3.3 | Predicate Device: K141338
cobas® Strep A w/ cobas® Liat® Analyzer Software 1.5.1 |
| 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 | PCR for detecting the presence / absence of bacterial DNA in clinical specimens |
| Detection
Technique | Same | Duplex assay using different reporter dyes for target and control |
| Result
Interpretation | Same | Automated - cobas® Liat® Analyzer (Rebranded from Liat™ Analyzer) |
| PCR Curve
Pattern
Recognition | Same | Yes, ensures abnormal PCR curves are called "Invalid" or "Indeterminate" |
| Assay Result | Same | Qualitative |
| User | CLIA Waived (CW140014) | Technologist in CLIA Moderate complexity labs |
| Time-to-result | Same | ~15 minutes |
| Error Diagnostic
System | Same | Yes, monitors and records system parameters for error recovery or assay abort if
unrecoverable |
| Limit of Detection | Same | 100 – 101 CFU per test |
| Reactivity | Same | Reactive against 9 Strep A strains tested |
| Cross Reactivity | Same | 63 human pathogens tested, including 13 other Streptococcus species, 42 other
bacteria, and 8 viruses. No cross reactivity found |
| Interfering
Microorganisms | Same | 63 human pathogens tested. No effect on detection |
| Item Name | Submitted Device:
cobas® Strep A w/ cobas® Liat® Analyzer Software 3.3 | Predicate Device: K141338
cobas® Strep A w/ cobas® Liat® Analyzer Software 1.5.1 |
| Interfering
Substances | Same | 28 substances at medically and/or physiologically relevant concentrations at near
LOD. No effect on detection |
| Sensitivity | Same | 98.5% (95% CI: 95.6% – 99.5%) |
| Specificity | Same | 94.2% (95% CI: 91.6 - 96.1%) |
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4. DESCRIPTION OF CHANGE: CORE SOFTWARE
cobas® Liat® Analyzer Software 3.3 incorporates the following changes:
- Operating System Migration to LINUX OS .
- Positive Patient ID .
- Translations (not applicable to US customers) .
- Enhanced Data Encryption .
- Thermal Printer Support .
- Generic Calculation Engine (not applicable to cleared assays) .
- Assay Masking .
- Integration of Advanced Tools .
- Correction of defects (bug fixes) .
5. DESIGN AND DEVELOPMENT ACTIVITY SUMMARY
Roche Molecular Diagnostics (RMD), Pleasanton, CA designed and developed the core software component of the cobas® Liat® System. The cobas® Liat® Analyzer core software was designed and developed by Roche Molecular Diagnostics in Rotkreuz, Switzerland.
RMD in Pleasanton and Rotkreuz coordinated the development and verification of cobas® Liat® Analyzer Software 3.3 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® Strep A assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Strep A assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version
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CONCLUSION 7.
Equivalent performance of the modified device and the current commercial device has been demonstrated, and analytical or clinical performance has not changed. The modified device is substantially equivalent to the predicate device, as cleared through K141338 and CLIA waived through CW140014.