FDA approved POC Fentanyl Urine Test with low cut off

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My medical director is looking for a POCT for urine for fentanyl with a low cut off (20 NG/ML) that is FDA approved.  I couldn't find one.  Any one using one or know of one?

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Any time I'm looking for an FDA approved Lab or Point of Care test, I always search the CLIA Medical Devices Database.  ( I always switch it over to the drop down selection method for the analyte and then identify the complexity I want).
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0
Attachment.
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CLIA - Clinical Laboratory Improvement Amendments (fda.gov)

We were recently looking for this as well. As far as I can tell, there is NO fentanyl test for medical use at POC. The only tests are forensic and not approved for medical use.

There are moderate solutions for this test but none that are CLIA waived for the Point of Care. 

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Donna McCalla
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