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

K191729 · Roche Molecular Systems, Inc. · OCC · Jul 24, 2019 · Microbiology

Device Facts

• Record ID: K191729
• Device Name: Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
• Applicant: Roche Molecular Systems, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Jul 24, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

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.

Device Story

The cobas® Influenza A/B assay is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of Influenza A and B viral RNA. The system uses a single-use disposable assay tube containing pre-packed reagents. The user adds a nasopharyngeal swab sample to the tube and inserts it into the cobas® Liat® Analyzer. The analyzer uses multiple actuators to compress the tube, moving the sample through segments to perform automated sample preparation, nucleic acid extraction (silica-magnetic bead-based), target enrichment, inhibitor removal, and real-time RT-PCR. An embedded microprocessor controls these processes. The detection module monitors the reaction in real-time; an on-board computer analyzes data and outputs interpreted results on an integrated LCD touch screen. Results can be printed or exported to LIS/middleware. The device is used in clinical settings to provide rapid (20-minute) diagnostic results, aiding healthcare providers in patient management and treatment decisions.

Clinical Evidence

No new clinical data was required. Performance was evaluated using data from previous submissions (K111386, CW150003), internal studies, release testing, and field data. Evaluation demonstrated that the modified FABA v1.35 script maintains equivalent performance to the predicate, with no changes to analytical or clinical performance characteristics.

Technological Characteristics

Multiplex real-time RT-PCR assay; utilizes cobas Liat System platform; software-based analysis; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for qualitative detection and differentiation of influenza A and B viral RNA in nasopharyngeal swab specimens from symptomatic individuals. Intended for use by healthcare professionals in point-of-care settings to aid in diagnosis.

Regulatory Classification

Identification

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Predicate Devices

• Liat™ Influenza A/B Assay (K111387)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K191729

B Applicant

Roche Molecular Systems, Inc.

C Proprietary and Established Names

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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OCC | Class II | 21 CFR 866.3980 - Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for software updates only.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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