CLIAWaiverApplication

CLIACategorizationOnly
PreviouslyClearedDevice

HemoCueWBCSystem
(K071652)

OfficialCorrespondent:
AllanWhite
QualitySystemsManager
HemoCue,Inc.
40EmpireDrive
LakeForest,CA926302244
(800)8811611x110
(949)8593066FAX
allan@hemocue.com
HemoCue WBC System

Onbehalfof:
HemoCueAB
Kuvettgatan1
S26271Angelholm,
SWEDEN

CLIA Waiver Application

Page 1 of 38

TableofContents

Introduction...................................................................................................................................... 3

DescriptionoftheHemoCueWBCSystem ...................................................................................... 4
2.1
IndicationsForUse................................................................................................................... 4
2.2
TheMeasuringPrinciple........................................................................................................... 4
2.3
Physicaldescriptionofthesystem........................................................................................... 4
2.3.1
TheHemoCueWBCAnalyzer ........................................................................................... 4
2.3.2
TheHemoCueWBCMicrocuvette ................................................................................... 5
2.4
AccessoriesandSpareParts..................................................................................................... 6
2.5
DescriptionofanAnalysis ........................................................................................................ 7
2.5.1
TestProcedure ................................................................................................................. 7
2.5.2
Results .............................................................................................................................. 9

DemonstratingthatHemoCueWBCSystemisSimpletoUse ....................................................... 10

DemonstratinginsignificantRiskofanErroneousResultFailureAlertandFailSafeMechanisms
11
4.1
4.2
4.3

RiskAnalysis ........................................................................................................................... 11
FailureAlertandFailSafeMechanisms................................................................................. 11
Conclusion .............................................................................................................................. 14

DemonstratinginsignificantRiskofanErroneousResultAccuracy............................................ 15
5.1
ObjectivewithFieldStudy...................................................................................................... 15
5.2
SummaryofFieldStudy ......................................................................................................... 15
5.3
DesignofFieldStudy .............................................................................................................. 15
5.4
PerformanceofFieldStudy.................................................................................................... 16
5.4.1
IntendedUseSettingsandIntendedUsers.................................................................... 16
5.4.2
Procedure ....................................................................................................................... 17
5.4.3
SampleMaterial ............................................................................................................. 17
5.4.4
FinancialDisclosure ........................................................................................................ 17
5.4.5
SelectionofComparativeMethod(CM) ........................................................................ 17
5.4.6
Specimencollectionandsampleanalysis ...................................................................... 19
5.4.7
StatisticalAnalysis(foreachsiteandcombined)........................................................... 19
5.4.8
TotalAnalyticalError...................................................................................................... 26
5.4.9
AllowableTotalError(ATE) ............................................................................................ 29
5.4.10 ResultfromQuestionnaire............................................................................................. 32
5.5
ConclusionoftheFieldStudy................................................................................................. 32

ProposedLabelling ......................................................................................................................... 33

Attachments ................................................................................................................................... 38

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Introduction

Apointofcaretestfortotalwhitebloodcellcount(WBC)hasbeendevelopedbyHemoCueAB.Thetestis
simpleandcanbeperformedinanydoctorsoffice.Thetestisperformedusingasmallamountofcapillaryor
venouswholebloodandtheanswerisavailablewithinminutes.TheHemoCueWBCsystemisusedfora
quantitativedeterminationofthewhitebloodcellcount.

ThepurposeofthissubmissionistodemonstratethatHemoCueWBCSystemissimpletouseandaccuratein
thehandsoftheintendedoperatorsandthatthereisaninsignificantrisktoobtainanerroneousresult.

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DescriptionoftheHemoCueWBCSystem
2.1

IndicationsForUse

TheHemoCueWBCSystemisindicatedforuseforquantitativedeterminationofwhitebloodcell(WBC)count
incapillaryorvenouswholeblood.TheHemoCueWBCSystemisforInVitroDiagnosticuseonly.The
HemoCueWBCAnalyzerisonlytobeusedwithHemoCueWBCMicrocuvettes.TheHemoCueWBCsystemis
indicatedforuseinclinicallaboratoriesandforpointofcaresettings.

2.2

TheMeasuringPrinciple

ThesystemconsistsoftheHemoCueWBCAnalyzertogetherwithspeciallydesignedmicrocuvettes,the
HemoCueWBCMicrocuvettes.Themicrocuvetteservesbothasasamplecontainerandareactionchamber.
Themicrocuvetteisforsingleuseonly.Abloodsampleofapproximately10Lisdrawnintothecavityby
capillaryaction.Ahemolysingagentlysestheredbloodcellsinthemicrocuvetteandastainingagentcolors
thewhitebloodcells.Animageistakenofthestainedwhitebloodcellsandthenumberofcellsiscountedby
imageanalysis.Theresultispresentedwithin3minutesontheanalyzersdisplay.

2.3

Physicaldescriptionofthesystem

2.3.1 TheHemoCueWBCAnalyzer
TheHemoCueWBCAnalyzer(Figure2.1)isaportabledevice.Themainpartsarethecuvetteholder(inwhich
themicrocuvetteisplaced),thecuvettemovingarm(bringsthemicrocuvetteintocorrectmeasuringposition),
amagnifyingopticunit,acamera,imageprocessingsoftware,adisplayandapoweradapter.

Figure2.1.TheHemoCueWBCAnalyzer

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TechnicalSpecifications

Optionaloutput

RS232forprinterconnection

Power

Batteries:6batteriestypeAA
Poweradapter:CEmarked,ULapproved
Input:100240VAC/5060Hz/200mA
OnlyuseadaptersrecommendedbyHemoCue,aslisted
underApprovedAdaptersintheOperatingManual

Dimensions:185x133x120mm(7.28x5.24x4.72inches)
Weight:600g(1.32pounds)(withbatteriesinstalled)

1535C(5995F),<90%noncondensinghumidity.
Allowtheanalyzertoreachambienttemperaturebeforeuse.

Physicalcharacteristics
Operatingenvironment
Storageenvironment

050C(32122F),<90%noncondensinghumidity

2.3.2 TheHemoCueWBCMicrocuvette
TheHemoCueWBCMicrocuvette(Figure2.2)ismadeofpolystyreneplasticandcontainssaponinthat
hemolyzestheredbloodcells,methylenebluethatstainsthewhitebloodcellsandnonactivereagents.A
bloodsampleofapproximately10Lisdrawnintothecavitybycapillaryaction.Themicrocuvetteservesas
samplecontainerandareactionchamber.Nodilutionofthesampleisrequired.

Figure2.2.TheHemoCueWBCMicrocuvette

TechnicalSpecifications

Composition

Themicrocuvetteismadeofpolystyreneplasticandcontainsthe
followingreagent:<20g/gmicrocuvettemethyleneblue,<500
g/gmicrocuvettesaponin,<400g/gmicrocuvette
Surfynol465,<400g/gmicrocuvetteTritonX100.

Physicalcharacteristics

Vialswith40microcuvettesineachvial

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Storageconditions

1535C(5995F),<90%noncondensinghumidity.

Anunopenedvialofmicrocuvettescanbestoredforashorter
periodoftime(upto4weeks)outsidespecifiedstorageconditions
(downto0C(32F)andupto50C(122F)

2.4

AccessoriesandSpareParts

Thefollowingaccessoriesandsparepartsareavailable:
Spareparts
Poweradapter
CuvetteHolder

Accessories
HemoCueCleanerWBC

Optionalaccessoriesbutnotsupplied
Lancets

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2.5

DescriptionofanAnalysis

2.5.1 TestProcedure
Pleasenotethatthecompletetestprocedureshouldbereadbeforeperformingthetest.

1. Pullthecuvettemovingarmouttotheloadingposition.Pressandhold
thebuttonuntilthedisplayisactivated.Thethreeflashingdashesandthe
HemoCuesymbolindicatesthattheanalyzerisreadyforuse.

2. TakeaHemoCueWBCMicrocuvettefromthevial.Keepunusedcuvettes
intheoriginalpackage.Donotremeasureoldcuvettes.

3. Makesurethepatientshandiswarmandrelaxed.Useonly
themiddleorringfingerforsampling.Avoidfingerswith
ringson.Cleanfingertipwithdisinfectantandallowtodry
completelyorwipeoffwithadry,lintfreewipe.
Usingyourthumb,lightlypressthefingerfromthetopofthe
knuckletowardsthetip.

4. Whileapplyinglightpressuretowardsthefingertip,puncture
thefingerusingalancet.
Wipeawaythefirsttwoorthreedropsofblood.

5. Whentheblooddropislargeenough,fillthemicrocuvetteinone
continuousprocess.DoNOTrefillthecuvette!NOTE:Makesurethat
themicrocuvetteisfilledfromthetip,placedatabouta45degreeangle
towardstheblooddrop.Lookforairbubblesinthefilledmicrocuvette.
Ifpresent,discardthemicrocuvetteandfillanewmicrocuvettefroma
newdropofblood.Smallbubblesaroundtheedgecanbeignored.

6. Wipeoffexcessbloodfromtheoutsideofthemicrocuvettewithaclean,
lintfreewipe.Donottouchtheopenendofthemicrocuvette.

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7. Placethefilledmicrocuvetteinthecuvetteholderwithin40seconds
afterfilling.Gentlypushthecuvettemovingarmtowardsthemeasuring
position.Itwillautomaticallyslidetothemeasuringpositionandthemeasurement
starts.

8. Afterapproximately3minutes,theWBCvalueisdisplayedasthe
numberofWBC/Linthespecimen.Theresultwillremainonthe
displayaslongasthecuvettemovingarmisinthemeasuringposition.
Donotremeasurethefilledmicrocuvette.
Note!Alwayshandlebloodspecimenswithcare,astheymightbe
infectious.Alwayswearprotectivegloveswhenhandlingblood
specimens.Consultlocalenvironmentalauthoritiesforproperdisposal.

9. Toturntheanalyzeroff,pressandholdthebuttonuntilthedisplayreads
OFFandthengoesblank.

2.5.2 Results
Thedisplayshowsanumericalvaluewhichisthenumberofwhitebloodcellsinthespecimen
withinthemeasuringrange0.330.0x109/L.
HHH
Measurementsabove30.0x109/LaredisplayedasHHH.
LLL
Measurementsbelow0.3x109/LaredisplayedasLLL.
ErrXX
ErrXXmeansthatanerrorhasoccurred.SeetheTroubleshootingGuideinthe

operatingmanualforadditionalinformation.

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DemonstratingthatHemoCueWBCSystemisSimpletoUse

HemoCueWBCsystemisafullyautomatedinstrumentnotrequiringanyinterventionbytheoperatorduring
theanalysis.Thesystemusesdirectunprocessedspecimennotrequiringanymanipulationofthespecimenor
ofthereagentbytheuser.
TheoperationofHemoCueWBCsystemdoesnotrequireanyspecialtrainingoftheoperator.TheHemoCue
WBCAnalyzeronlyhasonebutton,theon/offbutton,whichmakestheinstrument/userinterfaceverysimple.
Theoperatingmanualincludesathoroughtroubleshootingguidewithinterpretationoftheerrorcodeswith
explanationandactionsthatshouldbetakenbytheuser.AQuickReferenceGuideaswellasatrainingvideo
onCDROMareprovidedtotheusersatdeliveryofthedevice.Performancestudieshavebeenconductedto
demonstratethattheresultsobtainedbytheintendeduserarecomparablewithresultsobtainedbya
professionaluserandareferencemethod.
Thesystemdoesnotrequireanyelectronicormechanicalmaintenance.Ifanerrorcodeisshown,the
troubleshootingguideintheoperatingmanualclearlyindicatesiftheanalyzerneedstobesenttoHemoCue
fortechnicalsupport.
TheHemoCueWBCsystemperformsasystemintegritytestforeverysinglemeasurement.Asetofchecksare
performedatstartupandinbetweenthemeasurements.Whenpassingtheselftest,thedisplaywillshowthe
HemoCuesymbolandthreeflashingdashes,indicatingthattheanalyzerisreadytoperformameasurement.
Anerrorcodewillbedisplayediftheselftestfails.

Ablankingtestisperformedpriortothefirstmeasurementafterstartupoftheanalyzerandwhenthe
cuvettemovingarmismovedtoitsouterpositionduringnormaloperation.
Asystemsuitabilitytestisperformedforeachmeasurementbyutilizingthefocalqualityofthestainedcells.If
thecellscannotbefocusedproperly,anerrorcodewillappearandthemeasurementisinterrupted.
Severalinternalchecksensurethatonlyareaswithsuitablecelldistributionareusedforimageanalysis.No
additionalqualitycontrolsarerequiredforverificationofthesystemfunctionality.

Criticalerrorcodeslockstheordinaryprogramflowuntiltheanalyzeristurnedoff.Whenanoncriticalerror
occurs,theanalyzerisresetafterblanking.
Definition:Noncriticalerrorsareerrorsthatarecorrectedbyrejectingthemeasurement.

HemoCuehasnotidentifiedanyfailuremodeswhereuseofaqualitycontrolmaterialwouldprovide
additionalassuranceofthesystemsperformancethanthebuiltinselftestcontainedintheHemoCueWBC
Analyzer.

WhenananalysishasbeenperformedwiththeHemoCueWBCsystem,theresultsgivenareshownin
numericalfigures,notrequiringtheusertofurtherinterpretorconductsubsequentcalculations.

Basedontheaboveinformation,HemoCueABconsiderstheHemoCueWBCsystemsimpletouse.

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DemonstratingInsignificantRiskofanErroneousResultFailureAlertandFail
SafeMechanisms

4.1 RiskAnalysis
AriskanalysisfortheHemoCueWBCsystemforrisksassociatedwithhazardsandhazardoussituationsdueto
userskills,humanfactorsandforeseeablemisusehasbeenperformed.

TheriskmanagementhasbeenperformedaccordingtoISO14971andHemoCuesinternalprocedureforrisk
management(QI018).SeeAttachment1fortheriskanalysis.
4.2 FailureAlertandFailSafeMechanisms
Basedontheresultsoftheriskanalysis,flexstudieshavebeenconducted.Theflexstudieshavebeen
designedtochallengethesystemunderconditionsofstresstoidentifypotentialuserrelatedfailuresand
determinetherobustnessofthesysteminthehandsoftheuser.Studiesregardingfailsafeandfailure
mechanismshavebeenconductedunderconditionsthatstressthedeviceinordertodemonstratehowfail
safeandfailurealertmechanismrespondtosuchconditions.

Table4.1.
Potentialsourceof
erroridentified
(RiskanalysisID#
Attachment1)

Angleoffilling.

Deviationfromthe
definedprocedure
(fillingangle45anda
fillingplaceatthe
edgeofthe
microcuvette)

RiskNo.19

Timeoflatency.

Deviationfromthe
definedprocedure
(<40s)

RiskNo.32and33
Trytorunananalysis
withoutfillingthe
microcuvettewith
sample

(anunfilled
HemoCue WBC System

Flexstudyconsistoffilling
anglesandfillingplaces:
Fillingangle0
Fillingangle90
Fillingangle90
FillingplaceNo1
FillingplaceNo2

Meanofbias
(%)with95% Acceptance
criteria
confidence
levelorerror

codes

15to+15

orerror
0.4to1.7
code
0.8to1.0
0.8to3.0
0.7to1.6
0.2to2.5

Flexstudyconsistofdifferent
timeoflatency:
1minute
3minutes
5minutes
10minutes

0.7to1.8
0.1to2.3
0.1to3.2
1.3to2.0

15to+15
orerror
code

Alltimeof
latencyare
approved

Studytoshowthatempty
cuvettewillgiveanerrorcode

Errorcode

Errorcode

Approved

Typeofstudy

CLIA Waiver Application

Commentson
results
Allfillingangles
asfillingplaces
areapproved

Page 11 of 38

Potentialsourceof
erroridentified
(RiskanalysisID#
Attachment1)

microcuvetteplaced
inmeasuringposition)

RiskNo.25
Partlyfilled
microcuvette

(themicrocuvette
shouldbecompletely
filled(10L)inone
step)

RiskNo.15,16and24
Sampledilution.

(undilutedsample
shouldbeused)

Notidentifiedasa
foreseeablerisk.
However,flexstudy
hasbeendone.

Storageofsample
outsidedefined
temperature
conditions.

(Definedconditions
arestorageinroom
temperature(r.t.)
Upto48hours
stabilityinr.t.)

RiskNo30,31and38
Operating
temperatureoutside
definedconditions.

(Definedconditionsis
roomtemperature
(r.t.)forbothcuvette
andsample)

RiskNo.1and2
HemoCue WBC System

Typeofstudy

Meanofbias
(%)with95%
confidence
levelorerror
codes

Acceptance
criteria

Commentson
results

Flexstudyconsistofdifferent
leveloffilledcuvette:
filledwith5Lsample
filledwith2Lsample
Emptycuvette

1.9to+0.2
Errorcode
Errorcode

15to+15
orerror
code

Approvedresults

Flexstudyconsistofdifferent
dilutions:
Dilutionfactor1:5
Dilutionfactor1:10
Dilutionfactor1:20

8.5to+8.9
3.7to+7.6
8.8to+10.5

15to+15

Alldilution
factorsapproved

Studyconsistoftwo
temperatures:
48hoursinrefrigerator
48hoursinroomtemperature

+1.9to+11.6
3.3to+1.2

15to+15

Alltested
temperatures
approved

Flexstudyconsistofdifferent
cuvetteandsample
temperature:
r.t./+7C
r.t./+37C
+7C/+r.t.
+7C./+37C

3.8to1.4
1.2to+1.0
0.6to+1.3
1.4to+0.1

15to+15
orerror
code

Alltested
temperatures
forsampleand
cuvette
approved

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Potentialsourceof
erroridentified
(RiskanalysisID#
Attachment1)

Themicrocuvetteis
filledintwosteps.

(themicrocuvette
shouldbefilledin
onestep)

RiskNo.20

Wrongtypeof
sample.

(capillaryorvenous
samplecanbe
analyzed)

RiskNo.13and14
WrongHemoCue
productused,another
typeofmicrocuvette
toanotherHemoCue
system

(theWBC
microcuvetteshould
beused)

RiskNo.37
Themicrocuvetteis
contaminated
(e.g)/notclean

RiskNo.21and22
Coagulation.

RiskNo.28

93%Humidity.

(definedstorageand
HemoCue WBC System

Typeofstudy

Flexstudyconsistoffillingin
twosteps:
5+10L
2+13L

Meanofbias
(%)with95% Acceptance
confidence
criteria
levelorerror

codes

15to+15

orerror
11.8to8.2
code
0.2to2.7

Commentson
results
Both
combinations
approved

!Noteinpackage
insert

Flexstudyconsistofdifferent
typeofsamples
Humanurine
Humanurinewithblood
Plasma

Allsamples
not
containing
WBCbelow
the
measuring
range(LLL)

LLL
orerror
code

Alltypesof
samples
approved

Flexstudyconsistofdifferent
kindofmicrocuvettesfrom
HemoCuesystems
MicrocuvettsfromAlbumin
201,Monitor,Glucose201RT,
BGlucose,Glucose201,BHb,
Hb201+,Hb301,PlasmaLow
Hb,DonorHbChecker

Itwasnot
possibleto
positionany
typeof
cuvette

Notpossible
touseany
other
cuvettes

Alltested
variants
approved

Flexstudyconsistofdifferent
kindofdamagedcuvettes:
Scratchedcuvettesonboth
sides
Cuvettewithpowder
Cuvettewithfingerprints
Flexstudyconsistofpartly
coagulatedbloodsamples

3.4to1.1

1.1to+1.1
1.8to0.1
Notpossible
tofill
cuvetteswith
partly
coagulated
blood
samples
4.71to0.1

15to+15
orerror
code

Allkindof
damaged
cuvettesgave
approvedresults

15to+15
orerror
code

Approvedresults

15to+15
orerror
code

Approvedresults

Verificationstudy

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Potentialsourceof
erroridentified
(RiskanalysisID#
Attachment1)

operatingconditions
<90%humidity)

RiskNo.3
Operating
temperature

(definedoperating
temperature15to
35C)

RiskNo.1and2
Themicrocuvetteis
contaminatedwith
bloodontheouter
walls(theoutside)
duetopoorsampling
technique

RiskNo.17and23
HighlevelsofWBC.

(Themeasuringrange
isdefinedto0.3to30
x109/L)

RiskNo.5

Typeofstudy

Meanofbias
(%)with95%
confidence
levelorerror
codes

Acceptance
criteria

Commentson
results

Flexstudyconsistofdifferent
temperatures:
+12C
+15C
+40C

+0.2to+6.1
2.4to1.9
12.2to3.8

15to+15
orerror
code

Alltemperatures
resultedin
approvedresults

Verificationstudy

errorcode
E001

Errorcode

Approvedresults

Flexstudyconsistofsamples
withleukocytes>30x109/L

100HHH
>100error
codeorHHH

Errorcode
orHHH

Approvedresults

4.3 Conclusion
Allresultsfromconductedtestsmeetthepredefinedacceptancecriteria.Thereisnosignificantriskof
obtaininganerroneousresultwiththeHemoCueWBCsystemwhenusedbytheintendeduser.

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DemonstratingInsignificantRiskofanErroneousResultAccuracy

5.1 ObjectivewithFieldStudy
Thefieldstudywilldemonstrate,ascloseaspossible,howtheHemoCueWBCSystemperformsonactual
clinicalspecimensbyintendedoperatorsundertheconditionsofintendeduse.
5.2 SummaryofFieldStudy
AcomparisonoftheHemoCueWBCsystemusedbyanuntrainedintendeduser(WM)withtheSysmexXS
1000iusedbyaprofessionaluser(CM)wasconducted.Thestudyshowthat96.6%ofallresultsarewithinthe
ATEzone.

NosamplesatthecomparisonswerefoundoutsidetheLimitsofErroneousResults(LER),seebelow.
30

ATE

25

HemoCue WBC, x109/L

ATE

20
LER

15

10

LER

-------- X = Y
0
0

10

15

20

25
9

Sysmex XS-1000i, mean values, x10 /L

30

Figure5.1.ScatterplotinErrorgrid,HemoCueWBCvsSysmexXS1000i,x109/L

TheresultsinthisstudyfulfiltheacceptancecriteriaandherebyshowthattheHemoCueWBCSystemis
appropriateforuseinaCLIAwaivedlaboratoryaccordingtotherequirementsintheCLIADraftGuidanceof
2005.
5.3 DesignofFieldStudy
ThefieldstudywasdesignedinordertocomplywithTheDraftGuidanceforIndustryandFDAStaff:
RecommendationsforClinicalLaboratoryImprovementAmendmentsof1988(CLIA)WaiverApplications;
DraftGuidanceissuedSeptember7,2005.

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5.4

PerformanceofFieldStudy

5.4.1 IntendedUseSettingsandIntendedUsers
Fiveintendedusesettingsandatotalof11intendedusersparticipatedinthefieldstudyfortheHemoCue
WBCSystem.

Table5.1.Summaryofsites
Site
Numberof
Numberof
Totalnumber
capillary
Venous
ofsamples
samples
samples
DelfinenPrimaryCare
56(2*)
70
126(2*)
MunkaPrimaryCare
74(2*)
80
154(2*)
SjcronaPrimaryCare

70
70
PTCatngelholmHospital

60
60
NrlundaPrimaryCare
5

5
Total
135(4*)
280
415(4*)
*Numberofsamplesexcludedfromcalculationsduetoinsufficientsamplevolume.orresultoutsidedefined
measuringrange,seesection5.4.7.2.

Delfinen,Munka,SjcronaandNrlundaPrimaryCareCentersaredistricthealthcentersinprimarycare.They
areequivalenttoCLIAwaivedlaboratoriesintheUSA.ThefourthsiteisaPatientServiceCenteratngelholm
hospitalwherepatientscomeforbloodandurinesampling.Thesampleswerethenfurthertransportedto
laboratoriesforanalysis.ThestaffatthePatientServiceCenterhasthesamekindofassignmentsasthestaff
attheprimarycarecenters.

Theintendedusers(operators)inthisevaluationareassistantnurseswithalevelofhighschooleducation,and
nolaboratorytraining.ThisisequivalentwiththeexpectededucationallevelforintendedusersatCLIAwaived
laboratories.

Table5.2.Operatorinformation
Site
Operator
Age
Gender
Education
DelfinenPrimaryCare

41

female

Assistantnurse

DelfinenPrimaryCare

65

female

Assistantnurse

DelfinenPrimaryCare

2
3

42

female

Assistantnurse

MunkaPrimaryCare

55

female

Assistantnurse

MunkaPrimaryCare

55

female

Assistantnurse

SjcronaPrimaryCare

40

female

Assistantnurse

SjcronaPrimaryCare

47

female

Assistantnurse

PTCatngelholmhospital*

27

female

Assistantnurse

PTCatngelholmhospital*

31

female

Assistantnurse

PTCatngelholmhospital*

10

28

female

Assistantnurse

NrlundaPrimaryCare
11
*PTC=PatientServiceCenteratngelholmhospital

52

female

Assistantnurse

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5.4.2 Procedure
TheintendeduserswereprovidedwiththeHemoCueWBCSystemQuickReferenceGuide(Attachment2),the
draftHemoCueWBCPackageInsert(Attachment3),andtheHemoCueWBCSystemOperatingManual
(Attachment4).Theassistantnursesdidnotreceiveanytraining,coaching,prompting,writtenorverbal
instructionsbeyondthewrittentestprocedureandthesuppliedinstructionsforuse.

EachsamplewasanalyzedaccordingtoinstructionsforusewiththeHemoCueWBCSystembytheassistant
nurse(intendeduser)andinduplicatewiththeSysmexXS1000ibytheprofessionaluserfromHemoCue.All
samplesweremasked,i.e.theoperatorsdidnotreceiveanyinformationabouttheWBClevelforthesample.

Theevaluationtimewas4thofAprilto17thofOctober2007,during31workingdays.

Afterthestudywascompletedalltheintendedusersweregivenaquestionnaireinordertoevaluateifthe
participantsunderstoodhowtousethedevicecorrectlyandifitwaseasytouseandwhetheritfollowedthe
operatingmanualandpackageinsert.Thequestionnairecontainedquestionsconcerning:
1. themicrocuvette
2. theanalyzer
3. generalaspectsofthesystemandtheprovidedinstructionsforuse
4. theoverallimpressionofthesystemanditssimplicity

5.4.3 SampleMaterial
Intotal415humanbloodsampleswerecollectedandanalyzed.Thetestmaterialusedinthestudywere
capillaryandvenousbloodsamples:
LeftovervenousbloodsamplesfromClinicalChemistryLaboratoriesatngelholm,Halmstadand
HelsingborgHospitals.
CapillarybloodsamplesfrompatientsatDelfinenandMunkaPrimaryCareCenters
SpikedcapillarysamplesfromemployeesatHemoCueAB

5.4.4 FinancialDisclosure

SeeAttachment6.

5.4.5 SelectionofComparativeMethod(CM)
Thechosencomparativemethod(CM)istheSysmexXS1000i.TheSysmexXS1000iisanautomated
hematologyanalyzerforinvitrodiagnosticuseinclinicallaboratories.

TheSysmexXS1000iisacomparativemethodoftypeBwhichhastraceabilitytothemanuallightmicroscopic
WBCmethod(theReferenceMethod,RM).Themathematicalrelationshipisdefinedas1:1,seeTable5.3and
Figure5.3below.

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Table5.3.RelationshipbetweenCMandRM

Meanvalues,x109/L

Difference
between
Number
Manuallight methods
SysmexXS
of
microscopic
1000i
samples
WBCmethod
9
(CM)
x10 /L %
(RM)

WBC
level
x109/L

SD,x109/L
Sysmex
XS1000i
(CM)

CV,%

Manuallight
Manuallight
microscopic SysmexXS microscopic
WBCmethod 1000i(CM) WBCmethod
(RM)
(RM)

04.0
4.16.5
6.612.0
>12.0

19
33
23
34

2.52
5.46
8.98
22.59

2.23
5.36
8.91
22.48

0.29
0.10
0.07
0.11

13.0
1.9
0.8
0.5

0.04
0.09
0.19
0.26

0.25
0.43
0.38
0.50

1.6
1.6
2.1
1.2

11.2
8.0
4.3
2.2

Total

109

11.03

10.90

0.13

1.2

0.18

0.42

1.6

3.9

70

bo = 0.109 0.095
b1 = 1.002 0.006
r2 = 0.998
Syx = 0.501
N = 109

Sysmex XS-1000i all replicates, x10 /L

60

50

40

30

20

10

------- Y = X
0
0

10

20

30

40

50

60

70

Manual light microscopic WBC method, mean values, x109/L

Figure5.3.Regressionanalysis,SysmexXS1000i(CM)andManuallightmicroscopicWBCmethod
(RM)

HemoCue WBC System

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Page 18 of 38

5.4.6 Specimencollectionandsampleanalysis
SamplinghasbeendoneaccordingtoCDCRecommendationsandReportsGoodLaboratoryPracticesfor
WaivedTestingSitesSurveyFindingsfromTestingSitesHoldingaCertificateofWaiverUndertheClinical
LaboratoryImprovementAmendmentsof1988andRecommendationsforPromotingQualityTestingVol.54
/RR13.Note:thisisnotapplicableforthespikedcapillarysamplesfromHemoCue.

Capillary sampling:
Patients visiting
Primary Care

Patient identified
samples (age,
gender)

Result from
intended user
(WM)

Result from
professional user
(CM)

Intended user at
intended use site
collect sample in
microtube

Samples collected
in tubes

Intended user
performs analysis
on WM

Samples spiked
by HemoCue

Sample
transported to
HemoCue within 4
hours

Professional user
performs analysis
on CM
(in duplicate)

Professional user
performs analysis
on CM
(in duplicate)

Venous sampling:
Left over samples from patients
where WBC testing has been
ordered by physician

Capillary sampling:
Spiked samples from
HemoCue

Identified samples
(age, gender)

Sample split in two

Result from
professional user
(CM)

Sample
transported to
intended user site
within 4 hours

Intended user
performs analysis
on WM

Left over samples;

collection in tube
at hospital

Result from
professional user
(CM)

Professional user
performs analysis
on CM
(in duplicate)

Result from
intended user
(WM)

Sample
transported to
intended use site
within 4 hours

Intended user
performs analysis
on WM

Result from
intended user
(WM)

Figure5.4.Flowchartofthespecimencollectionandsampleanalysisusedinthefieldstudy

5.4.7 StatisticalAnalysis(foreachsiteandcombined)

5.4.7.1 StatisticalMethods
DescriptivestatisticsaccordingtoCLIADraftGuidanceof2005
o Mean,min,median,max,boxandwhiskerplots
o Scatterplot
Regressionanalysis
TotalAnalyticalError(TAE)

5.4.7.2 ExclusionofResults
Calculationswereperformedon411samples.ForsamplesP37,S12andH6thesamplevolumeweretoosmall
foranalysiswithSysmexXS1000i.SampleH49showedHHHontheHemoCueWBCsystem.Measurements
above30.0x109/LaredisplayedasHHHontheHemoCueWBC.ThemeanvalueonSysmexXS1000iwas
29.475forsampleH49.

5.4.7.3 DescriptiveStatistics
Thesampleshavebeendividedintothemedicalrelevantintervalsbasedonthemeanvaluesofthe
comparativemethod,i.e.SysmexXS1000i.

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Table5.4.SummaryrawdataMulticenterstudy
SysmexXS1000i,x109/L

HemoCueWBC,x109/L

WBC

Numberof

%of

x109/L

samples

total

Mean
values

Minvalues

Median
values

Max
values

Min
values

Median
values

Max
values

5.0
5.110.0
10.130.0

112
181
118

27
44
29

2.86
7.29
18.15

0.34
5.09
10.06

2.79
7.11
17.19

5.02
10.04
28.74

0.4
4.2
9.7

2.7
7.2
17.3

13.3
11.5
29.0

Total:

411

100

9.20

0.34

7.19

28.74

0.4

7.4

29.0

Table5.5.SummaryrawdataDelfinenPrimaryCare

WBC

Number
of

SysmexXS1000i,x109/L

%of

HemoCueWBC,x109/L

Mean
values

Min
values

Median
values

Max
values

Min
values

Median
values

Max
values

x109/L

samples

total

5.0
5.110.0
10.130.0

37
45
42

30
36
34

3.15
7.54
18.08

0.85
5.35
10.21

2.98
7.38
16.53

4.96
10.04
27.91

1.0
4.8
11.0

2.8
7.6
17.2

13.3
11.5
28.7

Total:

124

100

9.80

0.85

7.75

27.91

1.0

8.2

28.7

Table5.6.SummaryrawdataMunkaPrimaryCare

WBC

Number
of

SysmexXS1000i,x109/L

%of

HemoCueWBC,x109/L

Mean
values

Min
values

Median
values

Max
values

Min
values

Median
values

Max
values

x109/L

samples

total

5.0
5.110.0
10.130.0

34
79
39

22
52
26

2.80
7.24
17.44

1.18
5.09
10.06

2.74
7.03
17.08

5.01
9.96
28.61

1.3
4.2
9.7

2.9
7.1
17.3

4.7
10.6
28.5

Total:

152

100

8.86

1.18

7.12

28.61

1.3

7.3

28.5

Table5.7.SummaryrawdataSjcronaPrimaryCare

WBC

Number
of

SysmexXS1000i,x109/L

%of

HemoCueWBC,x109/L

Mean
values

Min
values

Median
values

Max
values

Min
values

Median
values

Max
values

109/L

samples

total

5.0
5.110.0
10.130.0

18
31
21

26
44
30

2.79
7.13
17.83

0.72
5.32
10.20

2.44
7.06
15.69

4.50
10.04
28.50

0.7
4.2
10.9

2.6
7.0
16.8

5.3
10.0
29.0

Total:

70

100

9.22

0.72

7.15

28.50

0.7

7.4

29.0

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Table5.8.SummaryrawdataPatientServiceCenter

Number
of

WBC

SysmexXS1000i,x109/L

%of

Mean
values

HemoCueWBC,x109/L

Min
values

Median
values

Max
values

Min
values

Median
values

Max
values

109/L

samples

total

5.0
5.110.0
10.130.0

19
26
15

32
43
25

2.54
7.22
20.55

0.34
5.25
12.80

2.34
6.93
20.02

5.02
9.89
28.74

0.4
4.4
13.0

2.3
6.8
18.2

4.8
10.2
27.0

Total:

60

100

9.07

0.34

6.74

28.74

0.4

6.4

27.0

Table5.9.SamplesanalyzedatNrlundaPrimaryCare(toofewresultstocalculatestatisticsforthissubgroup,
butthedataareincludedinTable5.4above.)
SysmexXS1000i,x109/L
repl1
repl2
mean

Sample

KH16
KH17
KH18
KH32
KH33

18.91
2.04
2.25
2.39
3.39

19.33
2.07
2.61
2.48
3.57

19.12
2.06
2.43
2.44
3.48

HemoCueWBC
x109/L
18.7
2.1
2.7
2.6
3.7

WBC count

30

20

10

HemoCue
WBC, single
replicate

Sysmex
XS-1000i, all
replicates

Figure5.5.BoxandwhiskersplotforMulticenterstudy,HemoCueWBCandSysmexXS1000i,x109/L.

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Page 21 of 38

WBC count

30

20

10

HemoCue
WBC, single
replicates

Sysmex
XS-1000i, all
replicates

Figure5.6.BoxandwhiskersplotforDelfinenPrimaryCareCenter,HemoCueWBCandSysmexXS1000i,
x109/L.

WBC count

30

20

10

HemoCue
WBC, single
replicates

Sysmex
XS-1000i, all
replicates

Figure5.7.BoxandwhiskersplotforMunkaPrimaryCareCenter,HemoCueWBCandSysmexXS1000i,x109/L

HemoCue WBC System

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Page 22 of 38

WBC count

30

20

10

HemoCue
WBC, single
replicate

Sysmex
XS-1000i, all
replicates

Figure5.8.BoxandwhiskersplotforSjcronaPrimaryCareCenter,HemoCueWBCandSysmexXS1000i,
x109/L.

WBC count

30

20

10

HemoCue
WBC, single
replicates

Sysmex
XS-1000i, all
replicates

Figure5.9.BoxandwhiskersplotforPatientServiceCenter,HemoCueWBCandSysmexXS1000i,x109/L.

HemoCue WBC System

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Page 23 of 38

30
Coefficients:
b0 = 0.056 0.131
b1 = 1.008 0.012

HemoCue WBC, x109/L

25

r2 = 0.986
Syx = 0.799
N = 411

20

15

10

-------- X = Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x10 /L

Figure5.10.RegressionanalysisandscatterplotforMulticenterstudy,HemoCueWBCvsSysmexXS1000i.

30
Coefficients:
b0 = 0.047 0.326
b1 = 1.027 0.027
2

HemoCue WBC, x109/L

25

r = 0.979
Sxy = 1.078
N =124

20

15

10

----- X=Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x10 /L

HemoCue WBC System

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Page 24 of 38

Figure5.11.RegressionanalysisandscatterplotforDelfinenPrimaryCareCenter,HemoCueWBCvsSysmex
XS1000i.
30
Coefficients:
b0 = 0.028 0.132
b1 = 1.015 0.012
r2 = 0.994
Sxy = 0.466
N = 152

HemoCue WBC, x109/L

25

20

15

10

----- X=Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x10 /L

Figure5.12.RegressionanalysisandscatterplotforMunkaPrimaryCareCenter,HemoCueWBCvsSysmexXS
1000i.
30
Coefficients:
b0 = -0.017 0.275
b1 = 1.012 0.024
r2 = 0.990
Sxy = 0.673
N =70

HemoCue WBC, x109/L

25

20

15

10

5
----- X=Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x10 /L

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Page 25 of 38

Figure5.13.RegressionanalysisandscatterplotforSjcronaPrimaryCareCenter,HemoCueWBCvsSysmex
XS1000i.
30
Coefficients:
b0 = 0.121 0.281
b1 = 0.954 0.024
r2 = 0.991
Sxy = 0.692
N = 60

HemoCue WBC, x109/L

25

20

15

10

5
------ X=Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x109/L

Figure5.14.RegressionanalysisandscatterplotforPatientServiceCenter,HemoCueWBCvsSysmexXS
1000i.

Difference (HemoCue WBC single repl..-Sysmex mv), x109/L

5.4.8 TotalAnalyticalError
10

-5

-10
0

10

20

30
9

Mean of HemoCue WBC and Sysmex XS-1000i, x10 /L

Figure5.15.BlandAltmanplotforHemoCueWBCuservsSysmexXS1000i,absolutedifferences,x109/L

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Page 26 of 38

Difference (HemoCue WBC single repl.-Sysmex mv), %

40

20

-20

-40

10

20

30

Mean of HemoCue WBC and Sysmex XS-1000i, x109/L

Figure5.16.BlandAltmanplotforHemoCueWBCuservsSysmexXS1000i,relativedifferences,%.Sample
KM18(155.3%)andH20(189.1%)areexcludedinthisplot.

Adjusted Cumulative Probability

0.6

0.4

0.2

0.0
-20

-10

10

20

30

Difference (HemoCue WBC- Sysmex XS-1000i) ,%

Figure5.17.Mountainplotforlowrange.Noacceptancelimits(0.4x109/L,15%)hasbeenincludedinthis
figure.SampleKM18(155.3%)andH20(189.1%)areexcludedinthisplot.

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Page 27 of 38

Adjusted Cumulative Probability

0.6

0.4

0.2

0.0
-20

-10

10

20

30

Difference (HemoCue WBC- Sysmex XS-1000i) ,%

15 % acceptance limits
Total error goal

Figure5.18.Mountainplotformediumrange.

Adjusted Cumulative Probability

0.6

0.4

0.2

0.0
-20

-10

10

20

30

Difference (HemoCue WBC- Sysmex XS-1000i) ,%

15 % acceptance limits

Figure5.19.Mountainplotforhighrange.

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Page 28 of 38


5.4.9 AllowableTotalError(ATE)
TheanalyticqualitygoalforWBCisestablishedinseveralpublicationsincludingCLIAtoallowatotalerror
(ATE)at15%Ref.1,2,3,4,5.

SuggestionofclinicalactionlimitshasbeenmadeinCLSI(NCCLS)H26ARef.6:
ClinicalRelevance:AbnormalResultsMayReflecttheFollowingConditions
<3x109/L Sepsis,chemotherapy,radiotherapy,agranulocytosis,marrowhypoplasia,cobalamin,folate,
irondeficiency.
>12x109/L Acutestress(includingsurgery),infection,malignancy,lymphoma,leukemia.

5.4.9.1 EstablishmentofanErrorGridforWBC
ThereexistsnoconsensuserrorgridforWBCcomparabletotheClarkeerrorgridforglucose.Accordingtothe
newCLIAguidelines,HemoCuethereforehasestablishedagridbasedonpatientriskandclinicalrelevance.
Atotalleukocytecountismeasuredindifferentsituationsinhealthcare:

Oneofthemostcommonsituationsistodetermineifaninfectionisbacterialorviral,ifthepatient
shouldbetreatedwithantibioticsornot.Usuallyacutoffvalueof12x109g/Lisused.Itcouldbea
severeconditionforthepatientifafalselowresultisreceivedandthetrueWBCisveryelevated.
Differenttypesofacuteleukemiawouldbecriticaltomiss.Patientswithacuteleukemiahavea
massiveincreaseofleucocytes.Gettinganormaloronlyaslightlyelevatednumberofleucocytes
missingacuteleukemiawouldbefatal.
AnotherpossiblesituationistomonitortheWBCduringchemotherapyorothercytotoxictreatment.
Avalueof3x109g/Lservesasadecisionleveltopermitcontinuationofthetreatment.Small
differencesherecouldcauserelativesevereconditions.EspeciallymissingapatientwithaWBCbelow
1x109g/Lorevenworse<0.5x109g/Lbecauseoftheincreasedinfectionrisk.

Withthisbackground,HemoCueestablishedthefollowingerrorgridwithzonesofATEandLER:

ATE:<15%or0.4x109g/Ltheallowabletotalerrorofdeviation.95%ofallsamplesshouldfall
withinthiszone.
LER:0%ofthesamplesmayfallintothesezones.TheupperleftLERzonecorrespondstoarisktomiss
patientswithleucopenia(<3x109g/L)duringchemotherapyorothercytotoxictreatment.Thelower
LERzonecorrespondstoarisktomisssevereinfectionsorleukemia.

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Page 29 of 38

WBC grid
30

25

ATE

LER

HemoCue

20

15

10

LER

0
0

10

15

20

25

30

Mean reference m ethod

Figure5.20.EstablishedWBCErrorGrid

LiteraturereferencestosupportestablishmentofWBCerrorgrid:
1. FraserC.G.,HyltoftPetersenP.,Qualitygoalsinexternalqualityassessmentarebestbasedonbiology,
ScandJClinLabInvest1993;53suppl212.ChapterI.Qualityplanning
2. FraserC.G.,TheNecessityofAchievingGoodLaboratoryPerformance,DiabeticMedicine1990;7:
490493.
3. FraserG.F.andPetersenP.H.,AnalyticalPerformanceCharacteristicsShouldBeJudgedagainst
ObjectiveQualitySpecifications.,ClinChem1999;45:3,321323.
4. RicsC.etal.,Currentdatabasesonbiologicalvariation,ScandJClinLabInvest1999,59:491500.
5. SebastinGambaroM..etal.,IntraandInterIndividualBiologicalVariabilityDataBank,EurJClin
ChemClinBiochem1997;35(11):845852
ThisdatabankisalsoavailableonthefollowingInternetaddress:http://www.westgard.com
6. NCCLSH26APerformanceGoalsfortheInternalQualityControlofMultichannelHematology
Analysers;ApprovedStandard.Vol.9No.9.December1996.

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5.4.9.2

ResultFieldStudyATE

30

ATE

25

HemoCue WBC, x109/L

ATE

20
LER

15

10

LER

-------- X = Y
0
0

10

15

20

25

30

Sysmex XS-1000i, mean values, x10 /L

Figure5.21.ScatterplotinErrorgrid,HemoCueWBCvsSysmexXS1000i,x109/L

Table5.10.NumberofsampleswithinATEandLERforeachWBCintervalandtotally

WBC
x109/L

Numberof
samples

%ofsampleswithinATE

%ofsampleswithinLER

5.0
5.110.0
10.030.0

112
181
118

93.8
97.2
98.3

0.0
0.0
0.0

Total

411

96.6

0.0

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Page 31 of 38

5.4.10 ResultfromQuestionnaire
1
(Strongly
disagree)

5
(Totally
agree)

2.Itiseasytoplacethecuvette
intotheanalyzer

11

3.Itiseasytoreadthevalue
fromthedisplay

11

4.Itiseasytounderstandthe
instructionforuseforthesystem

10

5.Itiseasytofollowthe
instructionforuseforthesystem

10

6.Itispossibletohandlethesystemusing
onlyQuickReferenceGuide

7.Itiseasytofindinformationabouthow
torectifyanerrorcodeiftheanalyzer
displaysone

Statement
1.Itiseasytofillthecuvette

Statement

8.IneededhelpthefirsttimeI
performedthetest

1
(Totally
agree)

5
(Strongly
disagree)

11

5.5 ConclusionoftheFieldStudy
TheresultfromthefieldstudyclearlyshowsthattheHemoCueWBCSystemissimpletouseinthehandsof
theintendeduserandthatthereisaninsignificantriskofreceivingerroneousresults.Thisisbasedonthe
factsthat96.6%ofallresultsfallswithintheATEzoneandtheintendedusersbelievesthatthedeviceisan
easysystemtouse.

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Page 32 of 38

ProposedLabelling

TheHemoCueWBCSystemisdeliveredtotheuserincludinganoperatingmanual,aquickreferenceguide,a
packageinsertaswellaslabelsshownbelow.Allapplicablelabellingispresentedinthischapter.

ProvidedwiththeHemoCueWBCSystemis:

QuickReferenceGuideHemoCueWBCsystemprovidedinAttachment2
PackageInsertHemoCueWBCMicrocuvettesprovidedinAttachment3
OperatingManualHemoCueWBCAnalyzerprovidedinAttachment4
TrainingCDHemoCueWBCSystemprovidedinAttachment5

TheHemoCueWBCSystemutilizesthelabelsshownonthefollowingpages.

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Page 33 of 38

Label,HemoCueWBCAnalyzer:DrawingCEandS/Nlabel,box

HemoCue WBC System

CLIA Waiver Application

Page 34 of 38

Label,HemoCueWBCAnalyzerboxlabel

Label,HemoCueWBCAnalyzerboxdrawing

HemoCue WBC System

CLIA Waiver Application

Page 35 of 38

Label,HemoCueWBCMicrocuvetteviallabel

HemoCue WBC System

CLIA Waiver Application

Page 36 of 38

Label,HemoCueWBCMicrocuvetteboxdrawing

HemoCue WBC System

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Page 37 of 38


Label,HemoCueWBCMicrocuvetteboxlabel(boxcontains4vials)

Attachments

Attachment1SafetyRiskAnalysisUserandSystemforHemoCueWBCSystemfollowup
Attachment2QuickReferenceGuideHemoCueWBCsystem
Attachment3PackageInsertHemoCueWBCMicrocuvettes
Attachment4OperatingManualHemoCueWBCAnalyzer
Attachment5TrainingCDHemoCueWBCSystem
Attachment6FinancialDisclosureStatement
Attachment7Rawdatasheetfromfieldstudy

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Page 38 of 38