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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK252259
Test Name Premier Biotech, LLC, Premier Biotech i3collect Cup  
Manufacturer NameAssure Tech., LLC
Consumer Information Phone Number1(888)686-9909
Test TypeOxycodone
Effective Date02/11/2026
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K252259
Device Name AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
Applicant
Assure Tech., LLC
1521 Concord Pike
Suite 201
Wilmington,  DE  19803
Applicant Contact Allen Chen
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH   QAW   QBF  
Date Received07/21/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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