For in vitro diagnostic use. Instrument cobas 6800 IVD cobas® 6800 system INS_2693 05 524 245 001 5 524 245 001 05524245001 5524245001 05524245001 cobas 6800 cobas® 6800 System 04015630935406 Instruments Not Available Not Available The cobas® 6800/8800 Systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT).The cobas® 6800/8800 Systems combine the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation. en Power rating International (Europe)US / CanadaPower Rating2 or 3 phase 200-240 V AC, 50/60 Hz208 V AC, 60 HzPower SupplyNo significant fluctuation, max. change ±10% Uninterruptible Power Supply (UPS)Highly recommended to connect IG server and instrument to a UPS Environmental conditions InternationalAmbient temperatureDuring Operation15-32°CAmbient humidity (relative humidity)During Operation30-80% (non-condensing)Pollution Degree 2 (IEC 61010-1)Altitude above sea level 0-2000 mOther environmental conditionsIndoor use onlyHorizontal installation spaceDust-free environment with adequate ventilationNo direct sunlightNo perceptible vibrationNo equipment generating electromagnetic waves in the vicinityNo machines discharging ultrahigh frequencies (e.g., electric discharger)Dimensions and weight SystemDimension / WeightHeightcobas ® 6800 System, including status lightcobas ® 6800 System, including status light216 cm221 cm (movable platform)Widthcobas ® 6800 System292 cmDepthcobas ® 6800 System129 cmWeight (Excluding / Including IG Server)cobas ® 6800 System, excluding IG server / including IG servercobas ® 6800 System, movable platform, excluding IG server / including IG server1517 kg / 1568 kg1675 kg / 1726 kg (movable platform)Space required around the system Platform TypeMinimum Space Required FrontMovable platformFixed platform100 cm100 cm BackMovable platformFixed platform50 cm80 cm en

cobas® 6800 system

Software 2.0*

IVD

Innovation inspired by you

As the healthcare landscape continues to change, Roche focuses on innovation that helps labs evolve with their needs, goals, and broadening menus. You spoke and we listened. Through our partnerships and customer feedback, we are evolving our solution to help you thrive as you grow.

The latest evolution of the cobas® 6800 system brings the innovation your lab needs to thrive and lead in continually changing and demanding times. Building on operation improvments and enhanced user experience, upgrade your current cobas® 6800/8800 systems or replace them with the new model.

This update is proof of our ongoing commitment to innovation within our platforms.

Flexibility on your terms—without compromise

The cobas® 6800 system offers fast time to results with the highest throughput and one of the longest walk-away times available among automated molecular platforms.^1-5

Bringing a new level of automation to laboratories, the cobas® 6800 system truly enhances efficiency and reduces manual effort. The system integrates and fully automates essential molecular testing steps, delivering significant work-away times, enabling your staff to focus on other essential operations.

New Software v2.0* features that focus on four key areas:

Flexible QC management: Customizable control concept gives you more options to run QC
More variety of tests per run: More unique assays per run (from 3 to 6), run IVDs and LDTs simultaneously
User-controlled prioritization: Set prioritized sample types, racks and /or tests so priority samples always run ASAP after loading
Intelligent scheduling: Automated and intelligent test scheduling for maximum efficiency with minimal sample idling

<b>cobas</b>® 6800/8800 v2.0* benefits at a glance

cobas® 6800/8800 v2.0* benefits at a glance

Absolute automation to elevate your lab to new performance heights

Walk away confidently after randomly loading your samples and let your system figure out the rest.

Pre-calibrated and ready-to-use reagents for easy and error-free handling
Onboard storage and refrigeration for consumables and reagents for less loading and long walk-away time
Full traceability from sample input to result with RFID and barcode-tagged reagents and consumables
Automated and intelligent test scheduling for minimal sample idling
Continuous scheduling of the optimal run assembly with your own defined rules for prioritization
- Prioritize assays so samples for specific tests run ASAP after loading
- Prioritize samples on the priority lane to include them in the next run
- Run QC at optimal intervals to maximize throughput and minimize costs

True consolidation to help you maximize operational efficiency

Consolidate >90% of routine testing on a single platform and streamline your workflows**

Up to 6 unique assays per run for more testing flexibility
Consolidation of low- and high-throughput testingefficiently
Full flexible ordering of TAGS and multi-target assays
Run IVDs and LDTs simultaneously in one plate
Broad assay menu that is clinically relevant, comprehensive, and focused on development for tomorrow
Fully automated open channel assays using cobas® omni utility channel

Proven integration to enhance the intelligence of the systems in your lab

Create a sophisticated ecosystem that optimizes efficiency

One-touch molecular testing from sample arrival to archival
Seamless integration of pre-analytical automation, analytics, overall operations, and operational reporting

Unrivalled standardization to allow for greater flexibility at any scale

Scale up operations easily with tailored solutions in Roche’s growing family of systems

Shared reagents for consistent results across the cobas® x800 family (cobas® x800 family includes cobas® 5800, 6800, and 8800 systems)
Same technology and hardware with proven reliability
Common software experience and workflows for streamlined training and minimized onboarding efforts

*The cobas® 6800/8800 System Software 2.0 and new model for the system are not yet available in the U.S.

**Dependent on molecular assay being run.

Improvement on throughput with the cobas® 6800 v2.0* second analytic unit

A second analytic unit can be added to your existing cobas® 6800 system, or you can replace your system with the new model, where the second analytic unit will be automatically included.

Explore the cobas® 6800 system

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

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

cobas® HIV-1
cobas® HBV
cobas® HCV
cobas® HIV-1/2 Qual
cobas® HBV RNA (RUO) ^‡
cobas® HDV (RUO) ^‡

Respiratory

Sexual health

Cervical health

cobas® HPV
cobas® HPV self-collection solution

Transplant

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 ^†

◊ Not available for sale on the cobas® 5800 in the U.S.

† 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.

Overview

Ordering information

Technical specifications

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Performance
Time to first results (up to 96 tests)	< 3.5 hours
Subsequent batches (96 tests)	Every 90 minutes thereafter
Maximum throughput (may vary based on workflow demands) (8 hours)<	384
Walk-away time (may vary based on workflow demands)	8 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

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Tube size	Acceptable measurement (mm)
Height	65–103
Outside diameter (includes barcode label)	12–16.2

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Dimensions and weight	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)
Instrument weight — Excluding instrument gateway server — Including instrument gateway server	1573 kg 1624 kg	1701 kg 1752 kg

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Onboard inventory
Samples	350
Assay reagent cassettes	Up to 12
Control cassettes	Up to 8
cobas omni MGP reagent	2
cobas omni specimen diluent reagent (1 L bottle)	2
cobas omni lysis reagent (1 L bottle)	2
cobas omni wash reagent (5 L bottle)	3
cobas omni processing plates	8
cobas omni amplification plates	8
cobas omni pipette tips	8

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Power supply
Line voltage	200–240 VAC +/- 10%
Line frequency	50/60 Hz +/- 5%
Maximum power	3500 VA
Insulation coordination	Installation Category II (IEC 61010-1)

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Barcode types supported

Codabar
Code 128
Code 39
Code Interleaved 2 of 5
Code 93
Code EAN-8
Code EAN-13 (including JAN code)

The cobas^® 6800 System only supports ASCII Codes 32–126 in the barcode.

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Pre-analytic solutions

The cobas® 6800 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

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Instrument gateway

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

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Contamination prevention

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

Technical documents

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Technical documents

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