cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for cobas Liat System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223591 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test is a Multi-Target Respiratory Specimen Nucleic Acid Test Including SARS-CoV-2 and Other Microbial Agents, designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral RNA. This automated multiplex real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay enables rapid, in vitro identification of these pathogens from clinical specimens.
Intended for use on the cobas Liat System, this test is performed in clinical microbiology laboratories by trained operators. Supplied as a single-use reagent kit, it requires no additional sterilization and is regulated under FDA 510(k) clearance (K223591) and the In Vitro Diagnostic Device Directive (IVDD). Compliance with regulatory standards ensures reliable performance for respiratory pathogen detection in healthcare settings.
Frequently asked questions
What clinical specimens can the cobas® SARS-CoV-2 & Influenza A/B test detect, and how does it differ from single-target tests?
The cobas® SARS-CoV-2 & Influenza A/B test is a multiplex nucleic acid test designed to simultaneously detect and differentiate SARS-CoV-2, influenza A, and influenza B viral RNA from respiratory specimens. Unlike single-target tests that require separate runs for each pathogen, this assay provides rapid, combined identification of all three viruses in a single workflow, improving efficiency in clinical microbiology labs. It is intended for use on the cobas® Liat® System, which automates the process for streamlined results.
Is the cobas® SARS-CoV-2 & Influenza A/B test single-use, and if so, how does this affect workflow in a lab setting?
Yes, the cobas® SARS-CoV-2 & Influenza A/B test is supplied as a single-use reagent kit, meaning each test requires a new kit for each run. This design eliminates the need for additional sterilization between uses, reducing contamination risks and simplifying workflow in clinical microbiology labs. The automated cobas® Liat® System is designed to handle these single-use components efficiently, ensuring consistent performance without manual reprocessing.
What regulatory pathways does the cobas® SARS-CoV-2 & Influenza A/B test follow, and how does this impact its use in healthcare settings?
The test is cleared under FDA 510(k) (K223591) and complies with the In Vitro Diagnostic Device Directive (IVDD), confirming its regulatory approval for use in healthcare settings. The clearance was granted through the Microbiology advisory committee under a Dual Track process, ensuring it meets stringent standards for detecting respiratory pathogens. This regulatory backing supports its reliability for clinical decision-making in microbiology labs.
How does the cobas® Liat® System integration affect the handling and storage requirements of the cobas® SARS-CoV-2 & Influenza A/B test?
The test is exclusively designed for use on the cobas® Liat® System, an automated platform that handles specimen processing, extraction, amplification, and detection in a closed system. While the test itself does not specify storage conditions beyond standard reagent protocols, the system’s integrated workflow ensures controlled handling, reducing the risk of contamination or degradation. Labs should follow the manufacturer’s guidelines for storing the single-use reagent kits and maintaining the Liat® System’s operational environment to preserve performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cobas® liat SARS-CoV-2, Influenza A/B & RSV, nucleic acid test, PDF cobas® SARS-CoV-2 & Influenza A/B - Roche Diagnostics USA, PDF K223591 - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223591 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (2)
- FDA 510(k) K223591 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026