U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 6 Silver Spring, MD 20993 www.fda.gov

July 26, 2019 Healthy.io Ltd Ron Zohar Chief Product Officer 2 Ibn Gabirol Street Tel Aviv, 6407702 Israel Re: K182384 Trade/Device Name: ACR | LAB Urine Analysis Test System

Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIR, KQO Dated: June 25, 2019 Received: June 25, 2019

Dear Ron Zohar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

K182384 - Ron Zohar Page

 

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Kellie Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

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Attachment3

510(K)SUMMARY

Healthy.io’sACR|LABUrineAnalysisTestSystemk182384

Submitter

Healthy.ioLtd.2IbnGabirolSt.TelAviv,6407702Israel Phone:+972-54-445-4514Fax:+972-77-470-4808ContactPerson:RonZoharDatePrepared:July2019NameofDevice:ACR|LABUrineAnalysisTestSystemCommonorUsualName:Smartphoneenabledalbumin-creatinineratioanalyzerRegulationSectionandClassificationName:

ClassI:AlbuminClassII:Creatinine21CFR§862.1645Urinaryproteinoralbumin(non-quantitative)testsystem21CFR§862.1225Creatininetestsystem21CFR§862.2900AutomatedurinalysissystemProductCode:

JIR JFY KQO ClassificationPanel:ClinicalChemistryPredicateDevice:

TheACR|LABissubstantiallyequivalenttothefollowingpredicatedevice:

Manufacturer Device 510(k)NumberACONLaboratoriesInc. MissionU120UltraUrineAnalyzer

andMissionUrinalysisReagentStrips(Microalbumin/Creatinine)

k142391

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DeviceDescription:

TheACR|LABUrineAnalysisTestSystemiscomprisedofasmartphoneapplication,aproprietaryColor-BoardandACRReagentStrips.Itisintendedforthesemi-quantitativedetectionofalbuminandcreatinineinurine,aswellasthepresentationoftheirratio.Thedeviceisprovidedasakitthatiscomprisedofacanisterof100FDA-clearedurineteststrips(ACONLaboratoriesInc.MissionUrinalysisReagentStrips(Microalbumin/Creatinine)k150330),10Color-Boards,andaUserManual.TheACR|LABUrineAnalysisTestSystemalsoconsistsofasmartphoneapplicationforuseoniPhone7device(iOS12),andanimagerecognitionalgorithmrunningontheBackend1.The softwarecomponentof theACR| LABconsistsofbothanapplication (App)andaBackendserver(Backend).TheAppinstructstheprofessionaluserhowtoaccuratelyperformthetest.TheAppconductsaseriesofboundaryconditionanalyses,andifthescanisapproved,sendstheinformationtotheBackendforcompleteanalysisandresultsclassification.Onceanalyzed,theresultsaresecurelytransmittedtoapatientElectronicMedicalRecordforreviewbyahealthcareprofessional.Thepatientsdonothaveaccesstotheresultsatanypointduringthetestingprocess.DeviceComponents:

TheACR|LABUrineAnalysisTestSystemiscomprisedofthefollowingcomponents:1. Acanisterof100MissionUrinalysisReagentStripsU031-021(ACONLaboratoriesInc.,k150330)2. TenindividuallywrappedColor-Boards 3. AsmartphoneApp4. Abackend,cloud-basedserver5. Ausermanual6. iPhone7withiOS12(notprovided)

IntendedUse/IndicationforUse:

TheACR|LABUrineAnalysisTestSystemiscomprisedofasmartphoneapplication,aproprietaryColor-Board,andACRReagentStrips.Itisintendedforthesemi-quantitativedetectionofalbuminandcreatinineinurine,aswellasthepresentationoftheirratio.TheACR|LABUrineAnalysisTestSystemisintendedforin-vitrodiagnosticusebyahealthcareprofessionalinapointofcaresetting.Theseresultsmaybeusedinconjunctionwithclinicalevaluationasanaidinthediagnosisforkidneyfunction.ComparisonofACR|LABandACONLaboratories’MissionU120UltraUrineAnalyzer:

Table1belowsummarizessimilaritiesandvariabilitiesbetweentheACR|LABanditspredicatedevice,ACON Laboratories’ Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips(Microalbumin/Creatinine)(k142391).

1 Backend will henceforth refer to the system’s cloud-based servers, which run the server-side

algorithms, and turn the algorithms’ analysis into clinical results. These are then securelytransmittedtoapatientElectronicMedicalRecord.TheACR|LABBackendisHIPAAcompliantandusesadvancedsecurityprotocolsfordatahandlingandtransmission.

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Table1:ComparisonbetweenACR|LABUrineAnalysisTestSystemandtheACONLaboratories’MissionU120UltraUrineAnalyzer(k142391)

Feature Healthy.io’sACR|LABUrineAnalysisTestSystem(k182384)

ACONLaboratories'MissionU120UltraUrineAnalyzerandstrips

(k142391)

IntendedUse TheACR|LABUrineAnalysisTestSystemiscomprisedofasmartphoneapplication,aproprietaryColor-Board,andACRReagentStrips.Itisintendedforthesemi-quantitativedetectionofalbuminandcreatinineinurine,aswellasthepresentationoftheirratio.TheACR|LABUrineAnalysisTestSystemisintendedforin-vitrodiagnosticusebyahealthcareprofessionalinapointofcaresetting.Theseresultsmaybeusedinconjunctionwithclinicalevaluationasanaidinthediagnosisforkidneyfunction.

The Mission® U120 Ultra UrineAnalyzer is a uranalysis instrumentintendedforinvitrodiagnosticuse.Itisintendedforprofessionaluseonlyatpoint-of-care locations. The MissionU120UltraUrineAnalyzerisintendedto read Mission® Urinalysis ReagentStrips (Microalbumin/Creatinine) forthe semi-quantitative measurementof albumin and creatinine. Thesemeasurements are used to assistdiagnosisforkidneyfunction.

TestSpecimen Urine Urine

DetectionMethodology

ReflectancePhotometry ReflectancePhotometry

Detectiondevice PhotosensitiveDiode PhotosensitiveDiode

OperatingConditions 0-35°C(32-95°F);≤93%Humidity(non-condensing)

0-40ºC(32-104ºF);≤85%Humidity(non-condensing)

Stripstobeused MissionUrinalysisReagentStripsU031-021(k150330)

MissionUrinalysisReagentStripsU031-021

StripOperatingConditions

15-30°C[59°-86°F]20%-80%Relativehumidity(non-condensing)

15-30°C[59°-86°F]20%-80%Relativehumidity(non-condensing)

StripIncubationTime 1minute 1minute

Calibration Automatic Automatic

PowerSource NotApplicable 6AAbatteries100-240VAC(adapter),(46-65Hz±1HZ)

LineLeakageCurrent NotApplicable <2.5mA

DataTransfer Via internet connection from theBackend to the dedicatedsmartphone as well as to a patientElectronicMedicalRecord(EMR)

USBport(datacommunications);Standard RS232C port for barcodereader or data transfer or externalprinter

Capabilities Transmission to EMR via internetconnection

Internal printer (included) 25 pinparallel external printer port

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Feature Healthy.io’sACR|LABUrineAnalysisTestSystem(k182384)

ACONLaboratories'MissionU120UltraUrineAnalyzerandstrips

(k142391)connector (included) barcode reader(optional)RS232CbarcodereaderBluetoothadapterEthernetviaUSBtoRJ45adapterUSBwirelessnet-card(optional)SDcardorUSBflashdriveforsoftwareupdate

Availablelanguagesonscreen

English(othersasinstalled) English(default)andadditionallanguages

Measuringcycle Approximately1minutepertest Approximately1minutepertest

Smartphones iPhone7 NotApplicable

OperatingSystems iOS12 NotApplicable

Dimensions 5.0cm(H)x23.2cm(W)x18.5(L) 260mm(L)x150mm(W)x175mm(W)

Weight <380g(notincludingthededicatedsmartphone)

<1.66kgwithoutbatteriesorpowersupply

SummaryofEquivalenceDiscussion:

ACR|LABanditspredicatedevice,ACONLaboratories’MissionU120UltraUrineAnalyzer(k142391),bothareintendedforprescription,invitrodiagnosticusebyahealthcareprofessionalinapointofcaresetting,withtestresultsreviewedbyaclinicianforfurthercare.TheMethodComparisonstudyresultsandbenchtestresultsdemonstratesubstantialequivalenceandprovideevidenceforthesafetyandeffectivenessoftheACR|LABUrineAnalysisTestSystemincomparisontotheACONLaboratories’MissionU120UltraUrineAnalyzerandMissionUrinalysisReagentStrips(Microalbumin/Creatinine)(k142391).

SummaryofPerformanceData:

Healthy.ioconductedbothbenchandclinicalstudiestotesttheaccuracyoftheACR|LABAnalysisTestSystem and its agreementwith its predicate device. These analytical and clinical performance studies(conductedinthreeindependentpointofcareclinicalsitesintheUnitedStates)aswellasthesoftwarevalidationtestingaresummarizedbelow.AnalyticalPerformanceTesting:

The performance characteristics of the ACR | LAB Urine Analysis Test System were evaluated by thefollowinganalyticalperformancetests:

Precision. This study was comprised of two separate sub-studies, including: 1) Repeatability; and 2)Reproducibility.TheprecisionstudiesweredesignedandexecutedinaccordancewithguidanceprovidedbyClinicalandLaboratoryStandardsInstitutedocumentEP05-A3–EvaluationofPrecisionofQuantitativeMeasurementProcedures;ApprovedGuideline–ThirdEdition.

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§ TheRepeatabilitystudywasconductedatthreesitesoverthecourseofoneday.EachoperatortestedthreespikedlevelsofurineusingtwentyACRReagentStrips(Strips)fromthreelotsonadedicatediPhone7device.Foreachanalyte,189totaltestswereperformedduringtheRepeatabilitystudy(189=3sitesX3solutionsX3lotsX7stripsX1phones).TheACR|LABdevicerecordedanexactmatchof100%duringthestudy.

§ TheReproducibilitystudywasconductedatthreesitesoverthecourseof20days,withtestoperatorsswitchinglocationseverysix-to-sevendays.Foreveryrun,eachoperatorusedadedicatediPhone7devicetotestthreespikedlevelsofurine.Todothis,theoperatorusedthreeStripspersample,oneStripeachfromthreeseparatelots.Fivedeviceswereusedthroughoutcourseofthestudy.Thesewererotated,withthreephonesusedonanygivenday.Foreachanalyte,1,080totaltestsweretakenduringtheReproducibilitystudy(3sitesx3solutionsX3lotsx2runsx20daysx1device).TheACR|LABdevicerecordedanexactmatchof99.8%duringthecourseofthestudy.

Interference.TestingofpotentialinterferingsubstanceswiththeACR|LABUrineAnalysisTestSystemwasdesignedandexecutedinaccordancewithguidanceprovidedbyClinicalandLaboratoryStandardsInstitutedocumentEP07–InterferenceTestinginClinicalChemistry–ThirdEdition;andEP37-SupplementalTablesforInterferenceTestinginClinicalChemistry,1stEdition.

§ Interferencewas defined as a change in output of≥ 1 color block between spiked and unspiked(control)samples.Once interferencewasdetected,adose-responsestudywascarriedoutatthreedecreasingintervalstodeterminethelowestconcentrationlevelthatcausesinterference.Interferingsubstances and their lowest concentrations causing interference were identified and listed in theaccompanyingUserManual.

LimitofDetection.TestingoftheACR|LABUrineAnalysisTestSystemLimitsofDetectionwasdesignedandexecutedinaccordancewithguidanceprovidedbyClinicalandLaboratoryStandardsInstitute(CLSI)documentEP17-A2–EvaluationofDetectionCapabilityforClinicalLaboratoryMeasurementProcedures;ApprovedGuideline–SecondEdition.

§ The Limit of Detection study was based on validated spiked or diluted urine solutions at knownconcentrationsforeachanalyte.Thesampleswereadjustedtoconcentrationsthatweredividedintofourequivalentintervalsbetweenthestatedcut-offblocs.Thecut-offforeachblockisdefinedasthelowestconcentrationatwhich>55%oftheresultswerepositive.

Linearity.ThelinearitystudyoftheACR|LABUrineAnalysisTestSystemwasdesignedandexecutedinaccordancewithguidanceprovidedbytheClinicalandLaboratoryStandardsInstitute(CLSI)documentEP6-A – Evaluation of Linearity ofQuantitativeMeasurement Procedures: A Statistical Approach; ApprovedGuideline.

§ TheLinearitystudytestedtheabilityoftheACR|LABUrineAnalysisTestSystemtoprovideresultsthataredirectlyproportional to theconcentrationsofanalyteswithineach test sample.ThestudytestedtheentirerangeofvaluesthattheACR|LABUrineAnalysisTestSystemisdesignedtomeasure.These expected values were presented against actual device results. Both of the analytesdemonstratedalinearrelationshipbetweenvariables,withnobiasesdisruptingtheoverallpatternoflinearity.

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TimingFlexStudy.Thisexperimentessentiallyconsistsoffourdifferentstudies:1.carry-over;2.dipping;3.wetting(blotting);and4.assay-time;andwasdesignedtoevaluatehowthetimingofdipping,wetting,andblotting,aswellascarry-overoftheStrips impactstheabilityoftheACR|LABUrineAnalysisTestSystemtoaccuratelymeasurethelevelsofalbuminandcreatinineinaurinesample.Theframeworkofthisstudyisbasedprimarilyonsimilarstudiesofdeviceswithsimilarindicationsforuse.

§ Carry-Over.Inthisstudy,stripswereheldinboththe"up"(withthecreatinineontop)and"down"(withthealbuminontop)positionsfordifferenttimeintervalsafterbeingdippedinspikedsolutions.Noneofthecarry-overtimedurations,inboth"up"and"down"configurationshadanyimpactontheACR|LAB'sabilitytomeasureaccurateresults.Thestudyusedthemostextremecases,testingforhigh-positive"run-off"intolow-positivepatches.

§ Wetting(Blotting)Time:Thisexperimenttestedsixdifferent"blotting"times,i.e.thetesterdippedtheStripandthenwaitedaspecificamountoftime(0-,5-,10-,20-,40-and60-seconds)beforeblottingtheStripandscanningitwiththeACR|LABdevice.Forcreatinine,noneofthevariousdippingtimesimpactedtheaccuracyofthedevice.Foralbumin,waiting60-secondstoblotthestripresultedinFalsePositiveresults.TheUserManualandin-appinstructionsdirecttheprofessionalusertodip,blot,andplacethestripontheColor-Boardinquicksuccession.

§ DippingTime.Stripsweredippedinspikedsolutionsforfourdifferenttimedurations(1-,2-,5-,and10-seconds)totesttheimpactofvariousdippingtimesontheACR|LAB'sabilitytoperformaccuratemeasurements.Forcreatinine,noneofthevariousdippingtimesimpactedtheaccuracyofthedevice.For albumin, at times 5- and 10-seconds therewas an increase in False Positive results. TheUserManualandin-appinstructionsdirecttheprofessionalusertodiptheACRReagentStripfor1-second.

§ Assay Time: This experiment testedhowdifferent assay times impacted theACR | LAB's ability tomeasure accurate results. Strips were dipped and then immediately blotted, per the device'sinstructions.Theuserthenwaitedapredeterminedamountoftime(60-,80-,100-,or120-seconds)beforescanningthestrip.NoneoftheassaytimedurationshadanyimpactontheACR|LAB'sabilitytoaccuratelymeasurealbuminorcreatinine.TheUserManualandthein-appinstructionsdirecttheprofessionalusertoscantheStripandColor-Boardoncethein-apptimerhasindicatedthat60-secondshaveelapsed.

Stability. This stability experiment was designed to test the ACR | LAB ability to provide accuratemeasurements after subjecting the device kit to both real time and accelerated aging timeframes andconditionsthatcouldariseduringtransportation(e.g.temperature,humidityandvibration).Inaddition,an open vial experiment was also conducted. After exposure to these transportation conditions andtimeframes,theperformanceofthekitswasevaluatedthroughanumberoffunctionaltests.TheACR|LABdevicewasnotaffectedbyanyoftheseparametersanditsstabilitywasthereforeconfirmed.

ClinicalPerformanceTesting:

MethodComparison.TheobjectiveoftheMethodComparisonstudywastotesttheACR|LAB'sdegreeofagreementwithitspredicatedevice,whenoperatedbyaprofessionaluseratapoint-of-carelocation

Theprimaryacceptancecriteriaforthestudywerethepercentofexactmatchand±1colorblockmatchbetweentheACR|LABUrineAnalysisTestSystemandthepredicate.Throughoutthetesting,theACR|

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LABUrineAnalysisTestSystemdemonstratedhighlevelsofaccuracyasdemonstratedbyitspercentofagreementwiththepredicatedevice.

StudyDesign

Thestudyevaluatednativeurinesamplesfrom375subjectsaswellas60contrivedsamplesatthreeU.S.clinical sites.TheACR|LABdevicewasprovided to thestudycoordinators.All subjectswereasked toprovideaurinesample.Twoseparatelabtechnicianswereresponsibleformeasuringeachurinesample.The first lab technicianmeasured the urine sample using the iPhone 7 device; the second technicianmeasuredtheurinesampleusingthepredicatedevice,theACONLaboratories’MissionU120UltraUrineAnalyzer(U120Ultra).Eachurinesamplewastestedtwiceintotal;oncewiththeiPhone7deviceandthensubsequentlywith the predicate device (U120Ultra). The results of the ACR | LAB device and resultsmeasuredbythepredicate(U120Ultra)werecompared.

StudyResults–Accuracy

The overall agreement (% exact match) between the ACR | LAB Urine Analysis Test System and thepredicatedevicewas89%foralbuminand84%forcreatinine.TheoverallagreementbetweentheACR|LABUrineAnalysisTestSystemandthepredicatedevicewhenmeasuringthealbumin-creatinineratiowas93%.The±1colorblock%agreementbetweentheACR|LABUrineAnalysisTestSystemandthepredicatedevicewas100%foralbumin,100%forcreatinine,and100%forthealbumin-creatinineratio.

ThehighrateswithwhichtheACR|LABmeasuredthesameresultsasthepredicateACONLaboratories’MissionU120UltraUrineAnalyzerdemonstratesubstantialequivalencebetweenthetwodevices.SoftwareValidation:

ValidationoftheACR|LABdevicesoftwarewasperformedaccordingtoclause14ofIEC60601-1(thirdedition) Software requirements, IEC 62304:2004 to IEC 62304 – 2006/AC 2008, Medical device, andSoftwarelife-cycleprocessesstandards.Thesoftwarerelateddocumentswerecomposedaccordingtothespecific IEEE standards and the FDAGuidance for the Content of Premarket Submissions for SoftwareContainedinMedicalDevices.TheSoftwareValidationdocumentssummarizethevalidationassessmentand demonstrate that the software meets the design requirements and all potential risks have beenmitigated.

InaccordancewiththeFDA’sguidanceformanagementofcyber-security inmedicaldevices,theOCR’sHIPAAregulationandISO27001:2013,Healthy.ioconductedacomprehensivehazardanalysis.Thecybersecurityanalysisreport,togetherwiththecybersecurityvalidationtestreportsummarizestheassessmentprocessforcybersecurityanddemonstratesthatthesoftwaremeetstherequiredlevelofcybersecurityprotection.

Conclusions:

TheclinicalandanalyticalperformancestudyresultsdemonstratethattheACR|LABUrineAnalysisTestSystemissubstantiallyequivalenttothepredicatedeviceMission®U120UltraUrineAnalyzerandMissionUrinalysisReagentStrips(Microalbumin/Creatinine)(FDA510(k):k142391).