cobas® 5800 System

Innovation made accessible

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
  • 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

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

The cobas® 5800 System is designed to deliver:

automation

Automation

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
consolidation

Consolidation

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
integration

Integration

Scale efficiently as demands change

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

Standardization

Ensure consistency across testing

  • The same assay menu, reagents and user interface as cobas 6800/8800 Systems 
  • Consistent workflows across all assays and instruments
5800

 

 

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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Performance

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Performance

Time to first results (up to 24 tests)*

Subsequent runs (24 tests)

• 2 hours 45 minutes

• Every 60 minutes thereafter

Maximum throughput (8 hrs | 24 hrs)* 144 | 528 tests
Walk-away time*

6 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).

Onboard inventory

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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

Compatible tubes

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Compatible tubes

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

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

Power supply

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Power supply

Line voltage

100-240 VAC 
+/- 10%

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

Dimensions and weight

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Dimensions and weight

Instrument dimensions

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

Instrument weight 


1374 lbs.

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
Molecular Assays

Blood-borne Disease**

HIV-1

HBV

HCV

HIV-1/2 Qual

Sexual Health

CT/NG+

TV/MG+

HPV**

BV/CV†+

MG Resistance†+

NG Resistance †+

Transplant

CMV**

EBV+

BKV+

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

‡  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 https://www.fda.gov/media/135659.