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

LCM — Predicate Candidate Screening

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

71 daysmedian FDA review time

233 days90th percentile

88clearances measured

K-number	Device	Applicant	Decided	Review days
K212952	Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phenc	Psychemedics Corporation	2022-04-18	214
K203489	SEFRIA PCP Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021-04-20	144
K181135	Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2019-01-24	269
K163220	Atellica CH Phencyclidine (Pcp)	Siemens Healthcare Diagnostics, Inc.	2017-04-06	141
K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-	Immunalysis Corporation	2015-09-04	31
K142044	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYM	Guangzhou Wondfo Biotech Co., Ltd.	2014-08-25	28
K131181	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE	Omega Laboratories, Inc.	2013-06-25	61
K122703	RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP	Biophor Diagnostics, Inc.	2013-04-25	233
K111928	PSYCHEMEDICS PHENCYCLIDINE EIA	Psychemedics Corp.	2012-05-01	300
K101746	THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY	Microgenics Corp.	2011-04-08	290
K093989	ORAL FLUID PHENCYCLIDINE	Roche Diagnostics	2011-01-25	397
K101059	OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDI	Omega Laboratories, Inc.	2010-07-12	88
K080431	RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH	Quantrx Biomedical Corporation	2009-01-08	324
K062094	VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS	Ortho-Clinical Diagnostics, Inc.	2006-11-22	121
K060353	ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000	Acro Biotech, LLC	2006-05-03	79
K042726	QUEST DIAGNOSTICS HAIRCHECK-DT (PCP	Quest Diagnostics, Inc.	2005-07-28	300
K043071	RANDOX PHENCYCLIDINE ASSAY	Randox Laboratories, Ltd.	2005-01-27	80
K043305	ONLINE DAT PHENCYCLIDINE PLUS	Roche Diagnostics Corp.	2005-01-10	41
K041578	QUICKSCREEN, MODELS 9177X AND 9178X	Phamatech	2004-09-10	88
K023109	AMEDICA DRUG SCREEN PHENCYCLIDINE TEST	Amedica Biotech, Inc.	2002-12-16	89
K020254	PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 001	Lin-Zhi International, Inc.	2002-05-10	106
K013096	PHENCYCLIDINE	Abbott Laboratories	2002-03-13	177
K012582	AMEDITECH IMMUTEST DRUG SCREEN PCP	Ameditech, Inc.	2001-11-30	112
K011730	ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STE	ACON Laboratories, Inc.	2001-08-09	65
K012107	LIVESURE PHENECYCLINE (PCP) SCREEN TESTS	Pan Probe Biotech, Inc.	2001-07-20	15
K010045	INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST	Alfa Scientific Designs, Inc.	2001-05-29	144
K010047	INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2001-05-29	144
K011161	MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL	Syva Co., Dade Behring, Inc.	2001-05-15	29
K010651	AT HOME DRUG TEST, MODEL 9133 T	Phamatech	2001-03-30	25
K002272	BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MO	Branan Medical Corp.	2000-11-22	119
K002776	MODIFICATION TO PROFILE -II	Medtox Diagnostics, Inc.	2000-09-28	22
K000399	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541	OraSure Technologies, Inc.	2000-05-15	98
K000402	SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLI	Drug Detection Devices, Ltd.	2000-04-18	71
K000462	URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CAT	Dade Behring, Inc.	2000-04-06	55
K994020	ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2	Roche Diagnostics Corp.	2000-01-27	62
K994030	ONTRAK TESTCUP 5, CAT. 07 6481 7	Roche Diagnostics Corp.	2000-01-27	62
K994017	ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1	Roche Diagnostics Corp.	2000-01-27	62
K993983	SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL	Syva Co.	2000-01-27	64
K994236	AT HOME DRUG TEST, MODEL 9133	Phamatech	1999-12-30	14
K993945	BIONIKE AQ PHENCYCLIDINE (PCP) TEST	Bionike Laboratories, Inc.	1999-12-07	18
K991698	REDI-TEST PCP	Redwood Biotech, Inc.	1999-08-25	99
K991505	MICRO-STRIP FOR PHENCYCLIDINE METABOLITES	Microdiagnostics, Inc.	1999-08-05	98
K983790	VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE	Sun Biomedical Laboratories, Inc.	1999-03-01	125
K981363	ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST	Tcpi, Inc.	1998-12-22	251
K982801	AUTO-LYTE PCP EIA, MODEL #1254U	OraSure Technologies, Inc.	1998-11-04	86
K981292	QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST	Syntron Bioresearch, Inc.	1998-05-26	47
K981019	QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST	Syntron Bioresearch, Inc.	1998-05-07	50
K974582	QUICKSCREEN ONE STEP PCP SCREENING TEST	Phamatech	1998-02-04	58
K972963	MODIFIED CEDIA DAU PCP ASSAY	Boehringer Mannheim Corp.	1997-09-22	42
K964355	ONTRAK TESTCUP 5 (MODIFICATION)	Roche Diagnostic Systems, Inc.	1996-12-13	42

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