cobas® 5800 System

Perfectly designed for productivity and performance

Built upon Roche’s proven molecular concepts, the cobas® 5800 System delivers premium performance in a compact versatile package. 

The cobas® 5800 System empowers laboratories to balance productivity, efficiency, and potential cost effectiveness with fully automated and standardized workflows, on demand testing and the proven reliability of Roche quality results.

cobas® 5800 System

Big on features, small in footprint

Add capacity, improve capability, streamline confidence.

  • 24 results available in 2 hours and 45 minutes
  • 144 results in <8 hours and
    up to 528 results in 24 hours
  • Broad menu of 20 assays*
  • Up to 15 assays on board at all times

* cobas 5800 assays are not commercially available in the U.S on the cobas® 5800. Pending PMA approval clearance. All other assays in development. 

  • Up to 6 different assays in a single run
  • Customizable control concept
  • Walkaway time up to 6 hours
  • Compact footprint: < 11.2 sq. ft.
  • Possibility to prioritize samples and assays

The cobas® 5800 System is designed to deliver:



Improve productivity and reduce error

  • Fully automated to minimize hands-on time and maximize staff productivity
  • Reduce manual errors and increase predictability in delivering results


Maximize the value of your lab space

  • Streamline your instrumentation with a broad and expanding menu of assays 
  • Run IVDs and LDTs on one system using the cobas omni Utility Channel


Scale efficiently as demands change

  • Connect seamlessly with your existing IT infrastructure
  • Generate laboratory-specific insights to drive efficiency and productivity


Ensure consistency across testing

  • The same assay menu, reagents and user interface as cobas 6800/8800 Systems 
  • Consistent workflows across all assays and instruments
Molecular Assays

Blood-borne Disease




HIV-1/2 Qual**

Sexual Health





MG Resistance†+

NG Resistance †+





Cobas omni Utility Channel for third-party tests and LDTs

+   In development for use with cobas 5800

**   Pending PMA approval for use with cobas 5800

***  Pending 510(k) clearance for use with cobas 5800

‡  For Life Science Research Use Only. Not for use in diagnostic procedures.

†  This product is in development. This product is not available for use in the U.S.

*   This test will be submitted to the FDA as a Master File and will not have a regulatory classification, and will not be cleared, licensed or approved by the FDA.

§  This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner

||   This workflow for the test has not been reviewed by the FDA. The test has been validated but FDA’s independent review of this validation is pending. This pooling workflow is distributed in accordance with Section IV.C of the FDA policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised) at

Transforming testing and treatment together

Roche has been pioneering innovation in molecular testing for decades and remains committed to supporting laboratories in meeting both their own needs and the needs of the patients everywhere.

Speak with your Roche representative to learn more

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