Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LAF — Predicate Candidate Screening

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

89 daysmedian FDA review time

383 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days
K203647	SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021-12-22	373
K210212	Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines	Psychemedics Corporation	2021-12-15	322
K201442	Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Imm	Diatron Group	2020-07-31	60
K170222	Rapid Tox Cup II	American Bio Medica Corp.	2017-08-15	202
K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2016-03-18	86
K142293	Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Or	Biophor Diagnostics, Inc.	2015-09-18	396
K150096	Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card)	Healgen Scientific,, LLC	2015-03-04	43
K150162	First Sign Drug of Abuse Dip Card Test, First Sign Drug of A	W.H.P.M., Inc.	2015-02-26	31
K133047	RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CA	Biophor Diagnostics, Inc.	2014-12-18	447
K131652	LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATO	Lin-Zhi International, Inc.	2014-03-21	289
K111927	PSYCHEMEDICS METHAMPHETAMINE EIA	Psychemedics Corp.	2012-05-01	300
K113661	LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE C	Lin-Zhi International, Inc.	2012-01-23	41
K112236	WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORP	Guangzhou Wondfo Biotech Co., Ltd.	2011-09-19	46
K101973	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETA	Omega Laboratories, Inc.	2011-08-16	399
K101753	THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY	Microgenics Corp.	2011-04-08	290
K093884	ROCHE FLUDI METHAMPHETAMINE	Roche Diagnostics	2011-02-25	434
K080455	RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE,	Quantrx Biomedical Corporation	2008-12-31	315
K080381	QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA	Quest Diagnostics, Inc.	2008-06-25	133
K062242	METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; C	Lin-Zhi International, Inc.	2006-09-29	58
K051577	IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS	Immunalysis Corporation	2005-10-04	112
K033299	ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVIC	ACON Laboratories, Inc.	2003-12-12	59
K023837	LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDM	Princeton BioMeditech Corp.	2003-09-15	301
K023101	AMEDICA DRUG SCREEN METHAPHETAMINE TEST	Amedica Biotech, Inc.	2002-12-16	89
K022589	ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP E	ACON Laboratories, Inc.	2002-10-28	84
K012998	AMPHETAMINE/METHAMPHETAMINE	Abbott Laboratories	2002-03-13	188
K012585	AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE	Ameditech, Inc.	2001-11-16	98
K011672	ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE	ACON Laboratories, Inc.	2001-07-31	62
K011610	LIVESURE METHAMPHETAMINE SCREEN TESTS	Pan Probe Biotech, Inc.	2001-06-08	14
K010496	CEDIA DAU AMPHETAMINES/ECSTASY ASSAY	Microgenics Corp.	2001-05-29	97
K003847	MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URI	Alfa Scientific Designs, Inc.	2001-05-29	168
K003845	MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URI	Alfa Scientific Designs, Inc.	2001-05-29	168
K010836	AT WORK DRUG TEST, MODEL 9147T AWT	Phamatech	2001-04-11	22
K003352	ESCREEN SYSTEM	Escreen, Inc.	2001-03-20	145
K993852	FIRST CHECK HOME DRUG TEST PANEL 4	Worldwide Medical Corp.	2000-11-29	383
K000096	ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686	Roche Diagnostics Corp.	2000-04-26	104
K000452	SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMI	Drug Detection Devices, Ltd.	2000-04-24	73
K000979	REDI-SCREEN	Redwood Biotech, Inc.	2000-04-10	14
K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	OraSure Technologies, Inc.	2000-04-03	192
K000447	QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSC	Phamatech	2000-03-07	26
K993982	SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/	Syva Co.	2000-01-27	64
K992634	IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5	Diagnostic Products Corp.	2000-01-20	167
K994233	AT HOME DRUG TEST, MODEL 9068	Phamatech	1999-12-30	14
K991504	REDI-TEST METHAMPHETAMINE	Redwood Biotech, Inc.	1999-07-22	84
K983189	DBEST METHAMPHETAMINES TEST KIT	Ameritek, Inc.	1998-11-18	68
K972556	QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)	Phamatech	1997-09-02	55
K961249	ACCUSIGN MET/BIOSIGN MET	Princeton BioMeditech Corp.	1996-04-25	24
K910043	TENONE(TM) METHAMPHETAMINE	Diagnostic Products Corp.	1991-02-14	41
K904413	CEDIA(TM) PHENOBARBITAL ASSAY	Microgenics Corp.	1990-11-05	40
K885071	COAT-A-COUNT METHAMPHETAMIN #TKMA1	Diagnostic Products Corp.	1989-01-09	32

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