<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>f131d667-e1d9-422f-b0b5-852cbaead32b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2022-06-10</publicVersionDate><devicePublishDate>2016-09-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00817405020249</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Alere iCup Dx</brandName><versionModelNumber>I-DXA-1107-142</versionModelNumber><catalogNumber>I-DXA-1107-142</catalogNumber><dunsNumber>019410187</dunsNumber><companyName>Instant Technologies, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC with adulteration tests Cr, Ni,pH, Bl, S.G., CLIA Waived</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>1-800-340-4029</phone><phoneExtension xsi:nil="true"/><email>Qa.Portsmouth@abbott.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K052115</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46994</gmdnCode><gmdnPTName>Multiple drugs of abuse IVD, kit, rapid ICT, clinical</gmdnPTName><gmdnPTDefinition>A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DIS</productCode><productCodeName>Enzyme Immunoassay, Barbiturate</productCodeName></fdaProductCode><fdaProductCode><productCode>JXM</productCode><productCodeName>Enzyme Immunoassay, Benzodiazepine</productCodeName></fdaProductCode><fdaProductCode><productCode>DIO</productCode><productCodeName>Enzyme Immunoassay, Cocaine And Cocaine Metabolites</productCodeName></fdaProductCode><fdaProductCode><productCode>LDJ</productCode><productCodeName>Enzyme Immunoassay, Cannabinoids</productCodeName></fdaProductCode><fdaProductCode><productCode>DJC</productCode><productCodeName>Thin Layer Chromatography, Methamphetamine</productCodeName></fdaProductCode><fdaProductCode><productCode>DJG</productCode><productCodeName>Enzyme Immunoassay, Opiates</productCodeName></fdaProductCode><fdaProductCode><productCode>DKZ</productCode><productCodeName>Enzyme Immunoassay, Amphetamine</productCodeName></fdaProductCode><fdaProductCode><productCode>DJR</productCode><productCodeName>Enzyme Immunoassay, Methadone</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="30"/><storageHandlingLow unit="Degrees Celsius" value="2"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="86"/><storageHandlingLow unit="Degrees Fahrenheit" value="36"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>