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

LDJ — Predicate Candidate Screening

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

81 daysmedian FDA review time

210 days90th percentile

150clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232732	Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) T	Co-Innovation Biotech Co., Ltd.	2024-01-17	132	0
K232604	LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine	Hangzhou Laihe Biotech Co., Ltd.	2024-01-10	135	0
K223162	Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Or	Healgen Scientific,, LLC	2023-03-17	161	0
K192515	BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test D	Shenzhen Bioeasy Biotechnology Co., Ltd.	2019-10-11	28	0
K153741	CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNG	Hangzhou Clongene Biotech Co., Ltd.	2016-03-18	81	0
K152643	EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-	Nantong Egens Biotech Co., Ltd.	2015-11-02	48	0
K151203	Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalys	Immunalysis Corporation	2015-06-05	31	0
K141320	LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Flu	Lin-Zhi International, Inc.	2015-05-28	373	0
K142408	FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Ke	Polymed Therapeutics, Inc.	2014-09-25	28	0
K140546	HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP	Healgen Scientific,, LLC	2014-06-06	94	2
K130213	QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE M	Lumiquick Diagnostics, Inc.	2013-10-18	262	0
K132096	RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC	Biophor Diagnostics, Inc.	2013-10-18	102	0
K122633	TOXCUP DRUG SCREEN CUP	Branan Medical Corp.	2013-02-07	162	0
K122759	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (TH	Omega Laboratories, Inc.	2012-12-05	86	0
K121557	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TES	Guangzhou Wondfo Biotech Co., Ltd.	2012-07-25	61	0
K111929	PSYCHEMEDICS CANNABINOIDS EIA	Psychemedics Corp.	2012-05-01	300	0
K102428	WUNDER TEST	Hien Helen Nguyen	2012-04-18	601	0
K110239	LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALI	Lin-Zhi International, Inc.	2011-06-23	148	0
K110182	CANNABINOIDS URINE TEST	Guangzhou Wondfo Biotech Co., Ltd.	2011-05-20	119	0
K092269	CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CON	Randox Laboratories, Ltd.	2011-04-08	619	0
K101744	THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY	Microgenics Corp.	2011-04-08	290	0
K082977	BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CU	Mk Bio, Inc.	2009-08-20	318	0
K080467	BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN	Applied Dna Technologies, Inc.	2008-11-25	278	0
K080872	AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BA	Amedica Biotech, Inc.	2008-08-19	141	0
K063164	VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS	Ortho-Clinical Diagnostics, Inc.	2006-12-28	71	1
K061556	AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,;	Amedica Biotech, Inc.	2006-07-21	46	0
K053034	ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATA	Acro Biotech, LLC	2006-06-06	222	0
K050936	ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG T	ACON Laboratories, Inc.	2005-06-24	71	0
K050878	ON CALL MULTI-DRUG HOME TEST CUP	ACON Laboratories, Inc.	2005-06-08	63	0
K050594	NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS,	Nano-Ditech Co.	2005-05-15	68	0
K050050	ON CALL MULTI-DRUG HOME TEST	ACON Laboratories, Inc.	2005-03-11	60	0
K041142	RANDOX CANNABINOIDS ASSSAY	Randox Laboratories, Ltd.	2004-11-23	207	0
K041221	ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (C	Accu-Stat Diagnostics, Inc.	2004-07-13	64	0
K040257	QUEST DIAGNOSTICS HAIRCHECK-DT (THC)	Quest Diagnostics, Inc.	2004-06-14	131	0
K040464	AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST	Amedica Biotech, Inc.	2004-05-17	84	0
K040629	ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE	Accu-Stat Diagnostics, Inc.	2004-05-05	56	0
K023648	VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DET	Sun Biomedical Laboratories, Inc.	2003-05-06	188	0
K030213	ONLINE DAT II CANNABINOIDS II	Roche Diagnostics Corp.	2003-04-11	80	0
K022955	AMEDICA DRUG SCREEN THC TEST	Amedica Biotech, Inc.	2002-11-06	62	0
K021887	CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071	Lin-Zhi International, Inc.	2002-08-15	69	0
K014066	LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN M	Princeton BioMeditech Corp.	2002-06-10	182	0
K014193	LIFESIGN DOA 4 (THC/OPI/COC/MET)	Princeton BioMeditech Corp.	2002-05-23	153	0
K013247	CANNABINOIDS	Abbott Laboratories	2002-03-13	166	0
K012390	NO STEP ON SITE DEUG TEST CUP	Drug Free Enterprises	2001-12-18	144	0
K011813	AMEDITECH IMMUTEST DRUG SCREEN THC	Ameditech, Inc.	2001-10-22	133	0
K012541	MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FA	Branan Medical Corp.	2001-09-04	28	0
K010921	ADVANTAGE MARIJUANA (THC) HOME DRUG TEST	Advantage Diagnostics Corp.	2001-06-25	90	0
K011300	EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229	Syva Co., Dade Behring, Inc.	2001-05-17	17	0
K003557	ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE S	ACON Laboratories, Inc.	2001-03-15	118	0
K010138	PROFILE II ER	Medtox Diagnostics, Inc.	2001-02-14	28	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