cobas® 4000 analyzer seriesFreedom to realize your lab’s potential

The comprehensive serum work area solution for workloads of up to 200 samples per day

cobas c 311 analyzer Passion for predictability in chemistry

•Unmatchedreagentefficiencies•Broadestmenuofchemistry

reagentsavailable•ProvenreliabilityofRoche/

Hitachiinstrumentation

cobas® e-services Labintelligenceatyourfingertips

•Immediatetroubleshooting viaremoteaccess

•Automaticallyupdatedassaylibrary•Advancedperformancemonitoring

cobas e 411 analyzer Peaceofmindinimmunology

•Unmatchedreagentefficiencies•FastestSTATassaysonthemarket

•Superiorperformance ofECLtechnology

Work area management solutions

Standardize&integrate yourdatamanagement

•Reducedvariability•Increasedefficiency

•EnhancedInformation

cobas® 4000 analyzer series

cobas c 311 analyzerPassion for predictability in chemistry

Thecobas c311analyzerofferstheultimateincon-venience,performanceandconfidenceforlaboratorieswithclinicalchemistryworkloadsof50-200samplesper day.

•Thecobas creagentpacksdelivermaximumhandlingconveniencewithminimumreagentwaste,liquidready-to-usereagentsand90dayaverageonboardreagentstability

•Withindustry-leadingparameterssuchasTina-quant® HbA1cwithautomatedpretreatmentofwholebloodsamples,thecobas c311analyzeroffersthebroadestassaymenuonthemarket

•Roche/Hitachiindesignandmanufacture,thecobas c311analyzercontinuesthelongtraditionofprovenreliability

cobas e 411 analyzerPeace of mind in immunology

SuccessortotheElecsys®2010,oneofthemost successfulimmunoanalyzerseverdeveloped,thecobas e411analyzerisaperfectcomplementtothecobas c311analyzer.

•Thecobas ereagentpacksofferbest-in-classhandlingconvenienceandreagentefficiencesforimmunochemistrytestingwithliquidready-to-usereagentsand60dayaverageonboardreagent stability

•9minuteSTATapplicationsfortroponin,CK-MB,myoglobin,hCGandPTHprovideunmatchedresponse times

•Astheheartofthecobas e411analyzer,ECL technologydeliverstheuniquecombinationofhighanalyticalsensitivity,widemeasuringrangesand 9minuteSTATapplicationsforunparalleledperfor-manceinimmunochemistry

Work area managementStandardize & integrate your data management

Oneworkareamanagementtoolextendingcapabilitiesofmostlaboratory information systems:

•Reducingvariabilitythroughconsistencyindecisionmanagement•Increasingefficiencybycomprehensiveworkflowtools•Activemanagementofresultsandpatientdataprovidingoptimal

informationmanagementforphysicians

cobas® e-servicesLab intelligence at your fingertips

•cobase-support–immediatetroubleshootingviaremoteaccessimprovingsystemuptimeandoperativeefficiency

•cobase-library–automaticupdatefunctionalitysafeguardingonlineaccesstomostrecentapplicationinformationonreagents,calibrators and controls

•cobase-LabPerformance*–offeringadvancedperformancemonitoringtoolsforefficientQCmanagement

•cobaslink-enablingcobase-servicesviasecuregatewayconnectionbetweenlaboratoryandRoche

* in preparation

Laboratory Network SolutionsWith the cobas® modular platform

Withthecobasmodularplatform,Rochehasdevelopedaplatformconceptthatdeliverscustomizedsolutionsbasedonacommonarchitectureforvariousworkloadsandtestingrequirements.Whetheryourunalargecentrallaboratoryormanageanetworkofsatellitelaboratories,Rochecanofferyouatailoredsolution.

Aboveyouwillfindourcurrentandfutureanalyzerseriesforyourlaboratory:

cobas 8000 modular analyzer series

cobas 6000 analyzer series

cobas 4000 analyzer series

Common applications forstandardizedpatientresults

Flexible configurations fortailor-madesolutions

Universal reagent carriers forsimplifiedlogistics

cobas user interface foreasytraining&flexiblestaff

cobas® modular platform – Benefits

COBAS,COBASC,COBASE,LIFENEEDSANSWERS, ELECSYSandTINA-QUANTaretrademarksofRoche.

©2010Roche

RocheDiagnosticsLtd.CH-6343RotkreuzSwitzerlandwww.roche.com 0

49

525

020

01 e

021

0

cobas® 4000 analyzer seriescobas c 311 assay menu

Substrates Enzymes Proteins

Albumin (BCP+BCG) ACP a1-Acid Glycoprotein

Ammonia ALP a1-Antitrypsin

Bicarbonate ALT / GPT a1-Microglobulin

Bilirubin-direct Amylase-tot. b2-Microglobulin

Bilirubin-total Amylase–pancr. Albumin (immuno.)

Calcium AST / GOT APO A1

Cholesterol Cholinesterase Acetyl APO B

HDL Cholesterol Cholinesterase Butyryl ASLO

LDL Cholesterol Cholinesterase Dibucain C3c

Creatinine enz. CK C4

Creatinine Jaffé CK-MB Ceruloplasmin

Fructosamine GGT CRP

Glucose GLDH CRP High Sensitivity

Iron HBDH Cystatin C

Lactate LDH Ferritin

Magnesium Lipase Haptoglobin

Phosphorus HbA1c (whole blood + hemolysate)

Total Protein Homocysteine 2

Total Protein U / CSF Electrolytes (ISE) IgA

Triglycerides Chloride IgG

Triglycerides GB Potassium IgM

UIBC Sodium Kappa Light chains

Urea / BUN Freelite™ Human Lambda Free2

Uric Acid Lambda Light chains

Freelite™ Human Lambda Free2

Lipoprotein (a)

Myoglobin

Prealbumin

RF

Soluble Transferrin Receptor

Transferrin

COBAS, COBAS C and LIFE NEEDS ANSWERS are trademarks of Roche.

©2010 Roche

Roche Diagnostics Ltd.CH-6343 RotkreuzSwitzerlandwww.roche.com

Drugs of abuse (DAT) Therapeutic drug monitoring (TDM) Others

Amphetamines Acetaminophen D-Dimer

Barbiturates Amikacin Anti-Thrombin III

Benzodiazepines Carbamazepine

Cannabinoids Digitoxin

Cocaine Digoxin

LSD1 Gentamicin

Ethanol Lidocaine 1

Methadone Lithium

Methadone Methabolite (EDDP) MPA-T

Methaqualone NAPA

Opiates Phenobarbital

Oxycodone 1 Phenytoin

Phencyclidine Procainamide

Propoxyphene Quinidine1

Salicylate

Theophylline

Tobramycin

Valproic Acid

Vancomycin

1 Assays currently under development2 Partner Channel

Last Update 02/2010

cobas c 311 analyzerPassion for predictability in chemistry

Electronic updates & downloads via cobas® e-services

College of American Pathologists (CAP) HbA1c Survey Data; Source: http://www.ngsp.org/prog/index.html; May 2008

11.0

10.0

9.0NGSPTarget

%H

bA1c

8.0

7.0

Abbo

tt

Arch

itect

Beck

man

Sy

nchr

onBi

o-Ra

d

D-1

0Bi

o-Ra

d

Varia

nt II

Turb

oO

lympu

s AU

Roch

e

Tina

-qua

nt® II

Toso

h A1

c

2.2

Plus

Vitro

s

5.1

FS

cobas c 311 analyzerPassion for predictability in chemistry

Conveniencecobas c packs for convenient handling

•Liquid,ready-to-usecobas c reagent packs simplifyhandling

•All-in-onecassetteforeachparameterstreamlines logistics

•Electronicupdatesanddownloadsensureseamless,error-freedatahandling

•Assay-specificpacksizesenableeconomicusageofroutineandesotericparameters

PerformanceFullmenuofhighperformanceassays

•WholebloodHbA1coffersbest-in-classperformance

•Highonboardstabilityallowscontinuousavailabilityofover40assays

•Over100assaysofferacomprehensiveclini-calchemistrymenu

•Highcalibrationstabilityandlot-to-lotcali-brationoptimizereagentuse

ConfidenceRobustdesignandsampleintegritychecks

•cobas c311analyzercontinuestheRoche/Hitachitraditionofreliableinstrumentation

•Intelligentclotdetectionensuresreliableresultswithoutworkflowdisruptions

•Contact-freeultrasonicmixingeliminatescarry-over

•Test-specificserumindicesensureresultintegritywithoutmanualvalidation

CAP GH2-A 2008 mid level (mean ± 2SD)

Full workstation consolidation •Thecobas c311analyzerisdesigned

tobeatruework-horseonaccountofproventechnology

•Itconsolidatesclinicalchemistrywithspecialproteins,DATsandTDMs

Serum work area integration •Combinedwiththecobas e411

immunoanalyzer,thesystemcanpro-cessupto95%ofyourserumworkareaworkload

•Workareamanagementsolutionsinte-grate sample and data management acrosssystems

Seamless laboratory networking •Aspartofthecobasmodularplat-

form,thecobas c311analyzeroffersconsistentresultswithothercobas c systems

•Universalreagentcarriersandana-lyticalcomponentsenableflexiblenetworksolutions

1 108samplepositionswithcontinuousrandomaccess&flexibleSTATprioritysettings

4 RobustISEunitusingindirectmethod

7 cobas®userinterfacestandardizedtoother cobassystems

2 66semi-disposablereactioncuvetteswithultrasonicmixingforreducedwaterconsumption

5 Multi-functionalreagentprobeutilizestooltopuncturesealedreagentcasettes

3 Sampleprobeequippedwithclotdetec-tionandvacuumdrying

6 42cooledpositionsforcobascreagentpacksenablefullmenuconsolidation

1

2

3

4

5

6

7

COBAS,COBASC,COBASE,LIFENEEDSANSWERSandTINA-QUANTaretrademarksofRoche.

Otherbrandorproductnamesaretrademarks oftheirrespectiveholders.

©2010Roche

RocheDiagnosticsLtd.CH-6343RotkreuzSwitzerlandwww.roche.com

cobas c 311 analyzerTechnical specifications

System Fullyautomated,randomaccessanalyzerforClinicalChemistry,Electrolytes&HomogeneousImmunoassays(HIA)

TestThroughput Upto300tests/hr(photometry),450tests/hr(ISEonly)and300tests/hr(mixed)

Reagent concept Barcodedcobas creagentpackswithconvenientpackaging&ready-to-usereagents

Onboardreagentcapacity Upto45assays(42cooledcassetteslots+3channelsforISE)

Programmableparameters Upto117photometric,3ISEtests,8calculatedparameters&3serumindices

Sampletypes Serum,Plasma,Urine,CSF&WholeBlood

Onboardsamplecapacity 108positionswithcontinuousaccess&STATinterruptcapability

Samplecontainertypes Primarytubes: 5–10mL(16x100,16x75,13x100,13x75mm)Samplecup: 2.5mLMicrocup: 1.5mLCupontube

Samplevolume 1.0to35µLin0.1µLsteps

Sampleclotdetection Yes

Minimumsamplevolume Primarytubes: 700µLSamplecup: 100µLMicrocup: 50µL

Samplebarcodetypes Code128,Codabar(NW7),Interleaved2of5,Code39

Systeminterfaces TouchscreenPC,RS232serialinterface,bi-directional,cobas®link(TeleServiceandautodownload)

Sampledatabase 10,000routine/STATsamples

Testmethods 1point,1point+prozonecheck,2point,2pointkinetic,2point+prozonecheck,3point,1point+kinetics,RateA,RateA+serumindex,RateAwithblank,RateB

Calibrationmethods Linear,non-linearmulti-points,2pointcalibration,K-factor,upto100calibratorspre-programmable, storageofupto180curves;Preventivecalibrationofstand-bycassettes.

QCmethods Real-time,individual&cumulativeQC;AutoQC;Upto100differentcontrolspre-programmable;PreventiveQCaftercalibrationofstand-bycassettes

Rerun/repeat/reflex Automaticrerun/manualreruns,repeats&automaticreflexsupported

Electricalrequirements Powerrequirements: 230/400VoltsAC3/N/PE,110VoltsAC1.5kVAFrequency: 50Hzor60Hz+/–0.5%

Water/wasterequirements Waterquality: Bacteriafree,de-ionisedwatersupplyresistanceof1.0µS/cmmax.Waterconsumption: Upto12l/hrduringoperationWaterpressure: 0.5–3.5kg/cm3(49–343KPa)Watertemperature: 15to30°CBiohazardswaste: SeparatecontainerlocatedinthesystemWalldrainforwaste: 100mmabovethefloor

Regulatorycompliance GS,CE,UL,C-ULcompliant

Operatingconditions Ambienttemperature/humidity: 15to32°C/30to85%(RH,withoutcondensation)Heat&noiseoutput: 2kcal/h;<65dB

Physicaldimensions Width: 134cmDepth: 86cmHeight: 126cmWeight: 270kg

cobas® 4000 analyzer seriescobas e 411 assay menu

Thyroid function Tumor markers Infectious diseases

Anti-TG AFP Anti-HAV total

Anti-TPO CA 125 II Anti-HAV IgM

Anti-TSHR CA 15-3 Anti-HBc

Calcitonin1 CA 19-9 Anti-HBc IgM

FT3 CA 72-4 Anti-HBe

FT4 CEA Anti-HBs

T3 CYFRA 21-1 Anti-HCV

T4 free PSA HBeAg

T-Uptake NSE HBsAg

Tg total PSA HBsAg confirmatory

Tg hs1 HBsAg quantification

TSH CMV lgG

Cardiac CMV lgM

CK-MB (mass) CMV IgG Avidity 1

Fertility / hormones CK-MB (mass) STAT HSV-11

ACTH Digoxin HSV-2 1

C peptide Digitoxin HIV Antigen

Cortisol Myoglobin HIV Antigen confirmatory

DHEA-S Myoglobin STAT HIV combi

Estradiol NT-proBNP HIV combi PT1

FSH Troponin T Rubella IgG

hCG+b Troponin T hs Rubella IgM

hCG STAT Troponin T hs STAT Toxo IgG

Insulin Troponin T STAT Toxo IgM

LH

Progesterone

Prolactin

SHBG

Testosterone

COBAS, COBAS E and LIFE NEEDS ANSWERS are trademarks of Roche.

©2010 Roche

Roche Diagnostics Ltd.CH-6343 RotkreuzSwitzerlandwww.roche.com

Maternal care Anemia Bone markers

free b hCG Ferritin b-CrossLaps

PAPP-A Folate Vitamin D3 (25-OH)

PlGF RBC Folate Intact PTH

sFLT-1 Vitamin B12 N-MID Osteocalcin

P1NP

PTH STAT

Rheumatoid Arthritis Critical care

Anti-CCP IL6

BRAHMS PCT Others

S100 IgE

1 Assays currently under development

Last Update 02/2010

cobas e 411 analyzerPeace of mind in immunology

11.0

10.0

9.0NGSPTarget

%H

bA1c

8.0

7.0

Abbo

tt

Arch

itect

Beck

man

Sy

nchr

onBi

o-Ra

d

D-1

0Bi

o-Ra

d

Varia

nt II

Turb

oO

lympu

s AU

Roch

e

Tina

-qua

nt® II

Toso

h A1

c

2.2

Plus

Vitro

s

5.1

FS

Bayer Centaur Abbott Architect Roche Elecsys DPC I‘lite 2000

PTH Precision Monitoring NEQAS 2006

Met

hod

prec

isio

n C

V %

Sample No.

4

369

6

8

10

12

14

16

18

370

371

372

373

374

375

376

377

378

379

380

385

386

387

388

389

390

391

392

393

394

395

396

397

398

399

400

401

402

403

404

Bayer Centaur Abbott Architect Roche Elecsys DPC I‘lite 2000

Met

hod

prec

isio

n C

V %

Sample No.

369

6

8

10

12

14

16

18

370

371

372

373

374

375

376

377

378

379

380

385

386

387

388

389

390

391

392

393

394

395

396

397

398

399

400

401

402

403

404

cobas e 411 analyzerPeace of mind in immunology

Conveniencecobas e packs for convenient handling

•cobas e reagent packs are liquid, ready-to-use and simplify handling

•All-in-onecassettepackagingforeachparameter combined with calibrators stream-lines logistics

•Automaticpackopening/closingensureslonger onboard stability

•Programming-by-loadingconceptensuresseamless, precise data handling

•Datareviewscreenprovidesquickresulttraceability

Enhanced data review screen

Elecsys assay performance in external ring-trials

Electrochemiluminescence (ECL) reaction principle

Performance9 min applications for speed and quality

•Over75assaysoffercomprehensivecover-ageof7indicationareas

•Highonboardstabilityandshelf-lifeallowcontinuous availability of both routine and esoteric parameters

•Disposabletipsandassaycupsforreactioneliminate risk of carryover

•Integratedsafetyfeaturesensureresultintegrity

ConfidenceECL technology: The gold standard

•Highanalyticalsensitivityenableslargemea-suring ranges and low sample volume

Measuringranges:Estradiol4-4,300pg/mL; Progesterone0-6ng/mL; TotalPSA0-100ng/mL;

SampleVolume: b-hCGrequires10µL;3rdGen TSHrequires50µL

•Activationwithvoltageforacontrolledreac-tion allows high precision to avoid unneces-sary repeats and reruns

•Shortincubationtimeenablesthetimelyavailability of innovative applications

Magnet

Ru2base state

TPA

PPP Photon

Platinum Electrode

PTH Precision Monitoring

Reaction Phase - Measuring Cell

Full workstation consolidation •Thecobas e411analyzerisdesigned

to deliver accurate results on account of proven ECL technology

•Itconsolidatesroutineendocrinologywith cardiac, cancer, bone and infec-tious disease markers

Serum work area integration •Combinedwiththecobas c311ana-

lyzer,thesystemprocessesupto95%of your serum work area workload

•Workareamanagementsolutionsinte-grate sample and data management across systems

Seamless laboratory networking •Aspartofthecobasmodularplat-

form, the cobas e411analyzeroffersconsistent results with other cobas e systems

•Universalreagentcarriersandana-lytical components enable flexible network solutions

1 CD-ROM,USB&printerportsenableefficient data management

4 cobas® touchscreen user interface is standardizedtoothercobassystems

7 Disposabletipsandcupseliminatecarryover

8 Measuring cell provides unmatched detection using ECL technology

9 Consumables and liquid waste are easily accessible

2 Alsoavailablerackversionwith75sample positions

5 18channelsenableuseofupto18parameters simultaneously

3 30 continuous random access sample positionswithSTATpriority

6 Easy removal of disposables via solid waste container

12 3

4

5

6

7

8

9

COBAS,COBASC,COBASE,LIFENEEDSANSWERS andELECSYSaretrademarksofRoche.

Otherbrandorproductnamesaretrademarks oftheirrespectiveholders.

©2010Roche

RocheDiagnosticsLtd.CH-6343RotkreuzSwitzerlandwww.roche.com

cobas e 411 analyzerTechnical specifications

System

Fullyautomated,continuousloadingandrandomaccesssystemforimmunoassayanalysisbasedonECLtechnology.Availableasadiskandracksystem.Systemcomponents:AnalyticalmoduleincludingtouchscreenPC

Test Throughput Upto86tests/hr

Reagentconcept cobasereagentpack: Ready-to-usereagentsOnboardreagentcapacity: 18channels/reagentslotsforupto18differentassaysEvaporationprotection: Automaticclosureofreagentlids

Programmableparameters Max60assaysdefinablevia2D-barcodeincludingallnecessaryinformation(programmingbyloading)

Sampletypes Serum,Plasma,Urineandothers

Onboardsamplecapacity Load/unloadcapacity: Disk: 30samples Rack:75sampleson15RDstandard5positionrackRacktypes: Routine,STAT,Control,CalibratorSTAThandling: Disk:Anyunoccupiedpositiononthesampledisk Rack:DedicatedSTATportonrackfeeder

Samplecontainertypes Primarytubes: 5–10mL;16x100,16x75,13x100,13x75mmSamplecup: 2.5mLCups on tube

Samplevolume 10to50µLpertest,dependingonassayprotocol

Sampleprobe Disposabletipsforindividualsampletoavoidcarryover;Sampleclotdetection;Liquidleveldetection

Samplebarcodetypes PDF417,Code128,Codabar(NW7),Interleaved2of5,Code39

Systeminterfaces TouchscreenPC,RS232serialinterface,bi-directionalStandardPCports(USB,ethernet,serialetc)forothercommunicationdevices

Sampledatabase 2,000resultsforroutine,STATandcontrols

Test methods Pre-definedassayprotocols(sandwich,competitive,titration)

Calibration methods 2-point calibration per lot or per cobas e reagent pack

QC methods IndividualQC;CumulativeQC;PreventiveQCaftercalibration

Rerun/repeat/reflex Rerun,repeatandreflexsupported

Electrical requirements Powerrequirements: 100–120VAC50/60Hzsinglephase or200–240VAC50/60HzsinglephasePowerconsumption: 1,000VA

Water/wasterequirements Watersupply: 3lcontainerWaterquality: ≤10µS/cmor≥0.1megaOhm,bacteria-freeLiquidwaste: 4lcontainerwithoverflowdetectionordirectdrainWaterconsumption: Approx.3lfor250tests/approx.12mL/cycle

Regulatorycompliance GS,CE,UL,C-UL,CB-reportandcertificate

Operatingconditions Ambienttemperature: 8to32°C(64.4°Fto89.6°F)Ambienthumidity: 20%to80%Noiseoutput: 60dbA(stand-bymode),63dbA(avg.duringoperation)

Physicaldimensions Width: 120to170cm(disk/rack)Depth: 73to95cm(disk/rack)Height: 56cm(w/oPCunit)Weight: Approx.170kg(disk)and210kg(rack)