Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DKZ — Predicate Candidate Screening

225 FDA 510(k) clearances under this product code; the 50 most recent screened below.

76 daysmedian FDA review time

251 days90th percentile

225clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240670	DRI Ecstasy Plus Assay	Microgenics Corporation	2024-10-30	233	0
K233019	AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid	Hangzhou AllTest Biotech Co., Ltd.	2023-12-13	82	0
K231137	Xenta Drug Screen Cup, Xenta Drug Screen Dipcard	Xenta Biomedical Science Co., Ltd.	2023-05-19	28	0
K200363	Quidel Triage® TOX Drug Screen, 94600	Quidel Cardiovascular, Inc.	2020-03-11	26	0
K191099	Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Scre	Atlas Medical	2019-10-03	161	0
K182719	Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPr	Quidel Cardiovascular, Inc.	2019-06-19	264	0
K182738	Single and Multi-Drug Rapid Test Panel With Adulteration (Ur	Hangzhou AllTest Biotech Co., Ltd.	2019-03-27	180	0
K180879	BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-	Shanghai Venture Bio-Tech Co., Ltd.	2018-12-14	255	0
K181945	QuickScreen Pro Multi Drug Screening Test, Model 9395Z	Phamatech, Inc.	2018-10-18	90	0
K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cu	Alfa Scientific Designs, Inc.	2018-02-23	128	0
K161251	CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE	Hangzhou Clongene Biotech Co., Ltd.	2016-08-30	119	0
K152122	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-V	Alfa Scientific Designs, Inc.	2016-06-24	330	0
K152908	UCP COMPACT DRUG TESTS	Ucp Biosciences, Inc.	2016-05-03	215	0
K152590	ACCU NEWS Drug Screening Test Card/Urine Cup	Coretests, Inc.	2016-04-15	218	0
K153465	AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Tu	Assure Tech. (Hangzhou) Co, Ltd.	2016-03-31	121	0
K152269	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), H	Healgen Scientific,, LLC	2015-09-09	29	0
K151213	UCP Drug Test Mini Cups	Ucp Biosciences, Inc.	2015-08-21	107	0
K142855	Omega Laboratories Hair Drug Screening Assay Methamphetamine	Omega Laboratories, Inc.	2015-07-28	301	0
K141748	RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL F	Biophor Diagnostics, Inc.	2015-05-20	324	0
K143500	Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysi	Immunalysis Corporation	2015-02-06	58	0
K142800	Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug	Co-Innovation Biotech Co., Ltd.	2014-12-11	73	0
K142580	Chemtrue Multi-Panel DOA DIP Card Tests	Chemtron Biotech, Inc.	2014-12-01	77	0
K141532	CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE	Guangzhou Wondfo Biotech Co., Ltd.	2014-07-14	34	0
K131069	QUICKSCREEN AMPHETINE 500 TEST	Phamatech, Inc.	2014-05-14	392	0
K132812	UCP MULTI-DRUG TEST KEY CUPS	Ucp Biosciences, Inc.	2014-03-06	178	0
K133968	WONDFO MULTI-DRUG URINE TEST CUP, PANEL	Guangzhou Wondfo Biotech Co., Ltd.	2014-02-25	61	1
K131653	LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS,	Lin-Zhi International, Inc.	2014-02-04	244	0
K131110	ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/	Co-Innovation Biotech Co., Ltd.	2014-01-15	271	0
K130082	GENPRIME DRUGS OF ABUSE READER SYSTEM	Genprime, Inc.	2013-12-20	340	0
K131645	INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASS	Alfa Scientific Designs, Inc.	2013-10-07	124	0
K131811	UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS	Ucp Biosciences, Inc.	2013-07-19	30	0
K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	Advin Biotech	2013-06-17	277	0
K121065	POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN D	Polymed Therapeutics, Inc.	2013-05-24	413	0
K130463	UCP HOME DRUG SCREENING TEST; CARDS, CUPS	Ucp Biosciences, Inc.	2013-05-15	82	0
K130811	PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE	Psychemedics Corp.	2013-05-02	38	0
K123863	UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS	Ucp Biosciences, Inc.	2013-01-09	26	0
K122961	WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAM	Guangzhou Wondfo Biotech Co., Ltd.	2012-12-21	87	0
K122419	UCP HOME DRUG SCREENING TEST CUPS	Ucp Biosciences, Inc.	2012-11-30	113	0
K122904	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W	Guangzhou Wondfo Biotech Co., Ltd.	2012-11-15	55	0
K121987	WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST	Guangzhou Wondfo Biotech Co., Ltd.	2012-08-01	26	0
K121339	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TE	Chemtron Biotech, Inc.	2012-05-17	14	0
K113046	AMEDITECH IMMUTEST MILTI-DRUG SCREEN	Ameditech, Inc.	2011-11-10	28	3
K111560	WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TES	Guangzhou Wondfo Biotech Co., Ltd.	2011-07-15	42	0
K110446	ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL	Roche Diagnostics	2011-05-03	76	0
K101745	THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY	Microgenics Corp.	2011-04-08	290	0
K092275	RANDOX ECSTASY (MDMA) ASSAY	Randox Laboratories, Ltd.	2011-03-01	581	0
K102203	CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TEST	Chemtron Biotech, Inc.	2011-01-20	169	0
K102210	LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPH	Lin-Zhi International, Inc.	2010-12-28	145	0
K093664	AMPHETAMINES II ASSAY	Roche Diagnostics Corp.	2010-07-28	243	0
K093114	THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY	Microgenics Corp.	2010-05-12	223	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda