cobas® 8800 System

Welcome to the future of molecular testing

cobas® 8800 System

Unrivaled diagnostic performance, today and into the future

The cobas® 8800 System can help you meet the growing needs of your lab with highly efficient workflows, from sample processing to result interpretation. Deliver trusted, reproducible results while rapidly completing your daily testing requirements.

 

cobas 6800

Generate trusted, reproducible results with proven performace

cobas 6800

Leverage absolute automation to drive increased effeciency

cobas 6800

Deliver unmatched flexibility to meet your molecular testing demands - today and tomorrow

FIRST AND ONLY high volume fully automated system with a moderate complexity classification

Proven performance

Rapidly complete daily testing requirements

  • Since the launch of the cobas 8800 in 2015, hundreds of systems have been installed delivering consolidated testing and increased efficiency for laboratories 
  • Delivers rapid time to result, completing up to 96 tests in about 3 hours
  • Provides trusted, reproducible results with assay performance held to the rigorous standards you expect from Roche
  • Delivers unparalleled throughput for routine molecular testing
cobas 8800 throughput
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Absolute automation

Fully automated workflow from sample transfer to results

cobas 8800

cobas 8800 system

4 hours workaway time*

Transform "walk-away" time into "work-away" time. Minimal and intuitive interactions reduce the potential for human error and free-up technicians for other tasks. 

  • Pre-Calibrated, ready-to-use reagents do not require thawing, mixing, pouring or calibrations. Load and go. 
  • Automated onboard storage and refrigeration system enable ready access and maintain inventory of consumables and reagents 

*May vary based on workflow demands.

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Molecular testing - at any volume - in three easy steps 

cobas 6800

1. Load reagents & consumables

cobas 6800

2. Load samples

cobas 6800

3. Empty waste & review results

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Unmatched flexibility

Flebible sample loading, processing, and testing

 

1

technician

1

system

run IVDs and LDTs on a single system with the cobas omni Utility Channel

20

assays in 2021

an expanded menu supports true test consolidation

 

1

system

1

single point of entry

lets the system do the work while staff performs critical tasks

350

sample capacity

supports continuous loading and the highest work-away time

 

30

minutes set-up

3

tests from one tube

and 3 tests simultaneously on up to 4 thermocyclers for ultimate testing flebibility

5,760

on-board test capacity

with 90-days stability

=
1052

results with 4 hour
work-away time

12

assays in on board

run the tests you want, when you want

0

no reagent preparation, no manual pipetting, no sorting or batching or setting up subsequent runs - 

the cobas 8800 System does it all for you

Contamination prevention

Built in features to ensure the highest quality and integrity of patient results with no daily maintenance

  • Airlock doors with HEPA filtration
  • Pipette tips with filter technology
  • Dedicated pipette tips for each sample transfer and for transfer of extracted nucleic acid
  • Automatic heat-sealing of cobas omni Amplification Plate
  • Amperase included in every assay
  • Stainless steel 8-fold needle popetting transfers assay-specific reagents, controls and other bulk reagents required for sample preparaton and amplification; washed after each use
  • No use of bleach on the systems
alt

 

With a broad on-demand assay menu, the cobas 8800 System allows you to run the tests you want, when you want. 
 
Further flexibility is possible with the cobas omni Utility Channel, a dedicated open channel for both IDV assays and high-volume labortory developed tests (LDTs). The cobas omni Utliity Channel creates an opportunity to broaden youjr menu and automated more testing on the cobas 8800 System.
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

**   HIV-1, HBV and HIV-1/2 Qual are pending PMA. HCV is pending 510(k) 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.

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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Overview

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Technical Documents

cobas® 6800/8800 Systems Specifications Comparison

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cobas® 6800/8800 Systems Specifications Comparison

Performance

  cobas® 6800 System cobas® 8800 System
Time to first results (up to 96 tests) < 3.5 hours
Subsequent batches (96 tests) Every 90 minutes thereafter Every 30 minutes thereafter
Maximum throughput * 
(8 hours)<
384 1056
Walk-away time * 8 hours 4 hours
Maximum number of tests per run 96 tests, including controls
Results released Plates of up to 96 tests, with up to 3 assays per plate
User interactions 1. Load/unload samples, load reagents and consumables as needed 
2. Remove waste (solid and liquid) 
3. Review and release results

Onboard inventory

  cobas® 6800 System cobas® 8800 System
Samples 350
Assay reagent cassettes Up to 12
Control cassettes Up to 8
cobas omni MGP reagent 2 4
cobas omni specimen diluent reagent 
(1 L bottle)
2 4
cobas omni lysis reagent (1 L bottle) 2 4
cobas omni wash reagent (5 L bottle) 3 6
cobas omni processing plates 8 16
cobas omni amplification plates 8 16
cobas omni pipette tips 8 16

Compatible tubes (both Systems)

Tube size Acceptable measurement (mm)
Height 65–103
Outside diameter (includes barcode label) 12–16.2
Tube dimensions acceptable for use on the cobas® 6800/8800 System:

Barcode types supported — both Systems (1–23 characters)

  • Codabar
  • Code 128
  • Code 39
  • Code Interleaved 2 of 5
  • Code 93
  • Code EAN-8
  • Code EAN-13 (including JAN code)
The cobas® 6800/8800 System only supports ASCII Codes 32–126 in the barcode.

Power supply

  cobas® 6800 System cobas® 8800 System
Line voltage 200–240 VAC +/- 10%
Line frequency 50/60 Hz +/- 5%
Maximum power 3500 VA 8200 VA
Insulation coordination Installation Category II 
(IEC 61010-1)

Dimensions and weight

  cobas® 6800 System cobas® 8800 System
Fixed Moveable  
Instrument dimension 292 x 216 x 129 cm 
(W x H x D)
292 x 222 x 129 cm 
(W x H x D)
429 x 216 x 129 cm 
(W x H x D)
Instrument weight 
— Excluding instrument gateway server 
— Including instrument gateway server
  
1573 kg 
1624 kg
  
1701 kg 
1752 kg
  
2354 kg 
2405 kg

Instrument gateway (both Systems)

  • Functions as a central server when interconnecting and operating multiple Systems
  • System interconnectivity: Up to 5 analytic systems and 4 poolers managed by a single instrument gateway
  • LIS connectivity: Uni- and bi-directional communication using HL7 standard protocol

Contamination prevention (both Systems)

  • Airlock doors with HEPA filtration
  • Pipette tips with filter technology
  • Dedicated pipette tips for each sample transfer and for transfer of extracted nucleic acid
  • Stainless steel 8-fold needle pipetting transfers assay-specific reagents, controls and other bulk reagents required for sample preparation and amplification; washed after each use
  • Automatic heat-sealing of cobas omni Amplification Plate

Pre-analytic solutions

  • The cobas® 6800/8800 Systems will accept primary and secondary uncapped tubes in standard 5-position sample racks and are designed to be compatible with laboratory automation and conveying systems

    *May vary based on workflow demands
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