escreen.com
xx.xxESCREEN SYSTEM
ESCREEN, INC.
ESCREEN, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1954435 | 3003110749 | ESCREEN, INC. | 1 | N | 2020-04-25 | 8140 Ward Parkway Suite 300 Kansas City MO US 64114 |
| 2032801 | 3004129879 | ESCREEN, INC. | 1 | N | 2020-04-25 | 1725 W Williams Dr Bldg F67&68 PHOENIX AZ US 85027 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10860429001012 | eCUP™ - The eScreen eCUP™ is a patented human urine collection device designed to allow for rapid, under-seal screening. The eCUP™’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCUP™ is placed into the eREADER™ device, its test strips are digitally screened for the presence or absence of drugs of abuse. | 800-881-0722 | clientservice@escreen.com |
| 10867802000273 | xCupTM - 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. | 800-881-0722 | xx@xx.xx |
| 10867802000280 | eScreen eCup - The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCup is placed into the eReader device, its test strips are digitally screened for the presence or absence of drugs of abuse. | 800-881-0722 | clientservice@escreen.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 178155 | 1580458313 | K003352 | ESCREEN SYSTEM | LAF | 2001-03-20 |
| 178158 | 1580458313 | K003352 | ESCREEN SYSTEM | LAF | 2001-03-20 |
| 178155 | 1327926846 | ||||
| 178155 | 1539088977 | ||||
| 178158 | 1539088977 | ||||
| 178155 | 1621109158 | ||||
| 178155 | 1921907931 | ||||
| 178155 | 2054205040 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LAF | 2 | 2001-03-20 |
PMN#
GUDID#
mCup® - MCP7A-001
2016-09-24
mCup® - MCP9A-001
2016-09-24
mCup® - MCP10A-001
2016-09-24
mCup® - MCP11A-001
2016-09-24
mCup® - MCP5A-001
2016-09-24
xCupTM - 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.
2016-09-24
eScreen eCup - The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCup is placed into the eReader device, its test strips are digitally screened for the presence or absence of drugs of abuse.
2016-09-16
eCUP™ - The eScreen eCUP™ is a patented human urine collection device designed to allow for rapid, under-seal screening. The eCUP™’s lid contains several embedded reagent test strips that are sensitive to the five-test SAMHSA (Substance Abuse and Mental Health Services Administration) profile cutoff levels. The lid’s test strips also detect and provide adulteration panels for pH, creatinine, and nitrites. When the eCUP™ is placed into the eREADER™ device, its test strips are digitally screened for the presence or absence of drugs of abuse.
2020-04-24
mCup® - MCP5-001
2016-09-24
eREADER™ - The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eREADER™ uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eREADER™ automatically reports a negative eCUP™ urine drug screen back to you via your account or another applicant tracking system.
2020-04-24
eREADER™ - The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eREADER™ uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eREADER™ automatically reports a negative eCUP™ urine drug screen back to you via your account or another applicant tracking system.
2020-04-24
eREADER™ - The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providingan automated, objective, confidential testing process. The eREADER™ uses bar code technology, coupled with optical imaging,to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes,the eREADER™ automatically reports a negative eCUP™ urine drug screen back to you via your account or another applicanttracking system.
2020-04-24
eREADER™ - The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providingan automated, objective, confidential testing process. The eREADER™ uses bar code technology, coupled with optical imaging,to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes,the eREADER™ automatically reports a negative eCUP™ urine drug screen back to you via your account or another applicanttracking system.
2020-04-24
eScreen eReader - The eScreen eReader is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eReader uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eReader automatically reports a negative eCup urine drug screen back to you via your account or another applicant tracking system.
2018-04-12
eScreen eReader - The eScreen eReader is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eReader uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eReader automatically reports a negative eCup urine drug screen back to you via your account or another applicant tracking system.
2016-08-26
xReader System - The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff 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 xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
2016-09-16