xCupTM DUE-1117X-071-01

GUDID 10867802000273

The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations: Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

ESCREEN, INC.

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Primary Device ID10867802000273
NIH Device Record Keyae833c52-e3d1-45c7-b1a0-f3f273111a6a
Commercial Distribution StatusIn Commercial Distribution
Brand NamexCupTM
Version Model NumberDUE-1117X-071-01
Catalog NumberDUE-1117X-071-01
Company DUNS014079359
Company NameESCREEN, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx
Phone800-881-0722
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100867802000276 [Unit of Use]
GS110867802000273 [Primary]

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-05-24
Device Publish Date2016-09-24

Devices Manufactured by ESCREEN, INC.

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10867802000235 - mCup®2021-05-24
10867802000242 - mCup®2021-05-24
10867802000259 - mCup®2021-05-24
10867802000266 - mCup®2021-05-24
10867802000273 - xCupTM2021-05-24The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations: Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
10867802000273 - xCupTM2021-05-24 The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, poin
10867802000280 - eScreen eCup2021-05-24 The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid con
00860429001022 - eREADER™2020-05-04 The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providin
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