cobas® 5800 system

Innovation made accessible
IVD For in vitro diagnostic use.
cobas® 5800 System

Confidently take on your lab’s changing needs

The cobas® 5800 system makes automation, consolidation, integration, and standardization more accessible than ever before. Roche's proven molecular concept now comes in a compact size, delivering premium performance and value-added utility from a small footprint.

The cobas® 5800 system supports an automated and integrated workflow to run polymerase chain reaction (PCR) based nucleic acid testing (NAT) for use by trained professionals in laboratory settings.1 The cobas® 5800 system combines the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.

The cobas® 5800 System shares its "DNA" with cobas® 6800 and cobas® 8800 Systems, boasting a common assay menu, reagent concept, and user interface. Improve the productivity of your floor space by running a broad menu of assays from a small footprint, using fully automated and standardized workflows.

Efficiency in a compact size

cobas 5800 efficiency

Flexibility with a broad menu

cobas 5800 flexibility

Roche reliability

cobas 5800 reliability

End-to-end fully automated workflow for less hands-on time, more flexibility

The cobas® 5800 is the latest innovation in the x800 family of analyzers, cost-efficient solutions that combine to meet the changing demands for labs of all sizes.
cobas® 5800 hotspots

Our broad and expanding portfolio of assays is held to rigorous standards

Get accurate and actionable results for enabling better clinical decisions

Available assays

Blood-borne disease
Sexual health
 
Cervical health

Testing in development

Respiratory
  • cobas® Respiratory flex 
Sexual health
  • Vaginal Health panel BV/CV 
  • cobas® STI home sampling claim extension 
  • cobas® Lesion panel (HSV 1/2, VZV & syphilis) 
Cervical health
  • cobas® HPV Next Generation (genotyping beyond HPV 16 & 18) 
  • cobas® HPV home sampling claim extension 
  • cobas®  HPV 5800/6800/8800 Surepath claim extension 

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

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

§ This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;

SARS-CoV-2 & SARS-CoV-2 Duo

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

SARS-CoV-2 & Flu A/B v2

This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and

SARS-CoV-2, SARS-CoV-2 Duo, & SARS-CoV-2 & Flu A/B v2

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.

Lab technicians working on Roches cobas Systems for centralized testing to improve operational efficiency

Streamline your workflow using Roche's Molecular Work Area solutions

Whether your lab is new to molecular testing, upgrading your equipment, or looking to expand output, you get big lab performance and small lab agility with scalable, cost-efficient solutions from Roche. Start here with the right products for your lab to develop a system that is scaled to your needs.

Learn more about the Roche Molecular Work Area

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Overview

Ordering information

Technical specifications

Performance  
Time to first results (up to 24 tests)* Subsequent runs (24 tests) • 2 hours 30 minutes
• Every 60 minutes thereafter
Maximum throughput (8 hrs | 24 hrs)* 144 | 528 tests
Walk-away time* Up to 8 hours
Test Format • Plates of up to 24 tests with up to 6 assays per plate
• Two 24 well thermal cyclers
User interactions • Load/unload samples, load reagents and consumables as needed
• Remove waste (solid and liquid)
• Review or auto-release results
Support for lab developed tests with the cobas omni utility channel • Develop and automate your own lab developed tests (LDTs) with up to 24 targets per plate
• Mixed processing of open channel assays** and Roche IVD assays
* May vary based on workflow demands.
** Open channel assays may include third-party assays, as well as routine lab-developed tests (LDTs).

Compatible tubes

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Compatible tubes

Tube dimensions acceptable for use on the cobas® 5800 System

Tube dimensions acceptable for use on the cobas® 5800 System

Tube size Acceptable measurement (mm)
Height 65–103
Outside diameter (includes barcode label) 12–16.2
Dimensions and weight  
Instrument dimensions

53 x 73 x 32 inches
(W x H x D)

Instrument weight 


1374 lbs.

Onboard inventory  
Sample capacity

• Up to 128 primary or secondary specimen tubes

• Up to 28 liquid based cytology vials (ThinPrep® PreservCyt Solution)

• Up to 80 samples loaded in 5-position racks

Reagent capacity Up to 15 (up to 7,200 tests)
Control mini racks Up to 16
cobas omni MGP reagent 1 (480 tests)
cobas omni specimen diluent reagent (1 L bottle)* 1 (240 tests)
cobas omni lysis reagent (1 L bottle) 2 (432 tests)
cobas omni wash reagent (4 L bottle)† 1 (240 tests)
cobas omni processing plates 24 4 (96 tests)
cobas omni liquid waste plates 24 4 (96 tests)
cobas omni amplification plates 24 8 (192 tests)
Processing tips‡ 3 x 96 (144 tests)
Eluate tips 2 x 96 (192 tests)
* Calculated for the addition of 350ul
† For 3-4 assays per run,
‡ 2 processing tips are needed per sample
Power supply  
Line voltage

100-240 VAC 
+/- 10%

Line frequency 50/60Hz +/- 5%
Maximum power consumption 1600 VA

Barcode types supported

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Barcode types supported

1D barcodes:
  • Code 128
  • Code 39
  • Codabar
  • Interleaved 2 of 5
  • EAN-8
  • EAN-13
  • Code 93
 
2D barcodes:
  • Data matrix ECC 200
  • Aztec code

X800 Data Manager

  • Functions as a central server when interconnecting and operating multiple systems
  • System connectivity: up to 3 analytic systems managed by a single x800 Data Manager
  • LIS Connectivity: uni- and bi-directional communication using HL7 standard protocol
  • Order/ Result Handling
  • User Management
  • Configurations for user, assay priority, etc
  • Can be accessed via web browser on laboratory PC

Contamination prevention

  • Airlock doors
  • Pipette tips with CO-RE filter technology
  • Single use consumables
  • Dedicated pipette tips for each sample transfer and for transfer of extracted nucleic acid
  • Stainless steel pipettes transfer assay-specific reagents, bulk reagent dispensing - washed after each use
  • Controls (RMCs) transferred with pipette tips
  • Automatic heat sealing of cobas omni Amplification Plate
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Reference

  1.  F. Hoffmann-La Roche. cobas® 5800 system SW1.0 User Guide (v2.3). 2024.

 

† Not all assays available. Some assays are in development, pending 510(K) clearance, or PMA approval.

‡ $16.1 billion USD invested in 2021, according to the Roche Annual Report 2021. Chairman's letter to shareholders. Available at: https://www.roche.com/investors/annualreport21#highlights. Accessed March 24, 2023.

* Research Use Only. Not for use in diagnostic procedures

+ In development for use with the cobas 5800.