← Product Code [OCC](/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC) · K200065

# 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 (K200065)

_Roche Molecular Systems, Inc. · OCC · Feb 10, 2020 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K200065

## Device Facts

- **Applicant:** Roche Molecular Systems, Inc.
- **Product Code:** [OCC](/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC.md)
- **Decision Date:** Feb 10, 2020
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3980
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## 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, Influenza A/B & RSV, and Strep A Nucleic acid tests are molecular diagnostic assays performed on the cobas Liat System. The system utilizes automated nucleic acid amplification technology to detect specific pathogens from clinical samples. The device is intended for use in clinical settings by healthcare professionals to aid in the diagnosis of respiratory viral infections and Streptococcus A. The current submission covers software updates to the previously cleared systems. The fundamental scientific technology, including the amplification and detection processes, remains unchanged. The system provides qualitative results to clinicians to inform patient management and treatment decisions.

## Clinical Evidence

No clinical data provided. The submission relies on design control activities, including risk analysis and verification/validation of software modifications, to demonstrate substantial equivalence.

## Technological Characteristics

Nucleic acid-based assay system; automated amplification and detection; software-controlled instrumentation. The fundamental scientific technology remains unchanged from the predicate devices. The modification is limited to software updates.

## Regulatory Identification

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

## Special Controls

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

## Predicate Devices

- cobas® Influenza A/B Nucleic Acid Test for use on the cobas® Liat® System ([K191729](/device/K191729.md))
- cobas® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System ([K153544](/device/K153544.md))
- cobas® Strep A Nucleic Acid Test for use on the cobas® Liat® System ([K141338](/device/K141338.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K200065

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, 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

## 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  |
|  OZE | Class II | 21 CFR 866.3980 - Respiratory viral panel multiplex nucleic acid assay | MI - Microbiology  |
|  PGX | Class II | 21 CFR 866.2680 - Streptococcus spp. nucleic acid-based assay | MI - Microbiology  |
|  OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry  |

## II Review Summary:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II devices 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).
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 the modified subject devices have been reviewed to verify that the indication/intended use for the devices are 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 devices be determined substantially equivalent to the previously cleared devices.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K200065](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K200065)

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