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

DJC — Predicate Candidate Screening

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

107 daysmedian FDA review time

258 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K253705	Healgen® Accurate Oral Fluid Drug Test	Healgen Scientific,, LLC	2026-03-16	112
K240287	LYHER® Oral fluid Multi-Drug Test Kit (Cube)	Hangzhou Laihe Biotech Co., Ltd.	2025-03-18	411
K180878	BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO	Shanghai Venture Bio-Tech Co., Ltd.	2018-12-17	258
K181305	OralTox Oral fluid Drug Test	Premier Biotech, Inc.	2018-09-20	126
K171403	OralTox Oral Fluid Drug Test	Premier Biotech, Inc.	2018-02-02	266
K161044	AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cu	Assure Tech. (Hangzhou) Co, Ltd.	2016-07-06	84
K132630	WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAM	Guangzhou Wondfo Biotech Co., Ltd.	2013-09-27	36
K080347	UNISCAN -DOA SYSTEM	Taiwan Unison Biotech, Inc.	2008-10-09	244
K060355	ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000	Acro Biotech, LLC	2006-08-07	175
K060896	MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT	Varian, Inc.	2006-06-09	67
K053033	ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG#	Acro Biotech, LLC	2006-06-06	222
K031497	AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST	Amedica Biotech, Inc.	2003-10-17	157
K022388	STARTOX DRUG OF ABUSE SCREENING TEST (4)	Starplex Scientific, Inc.	2003-02-27	219
K022501	INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST	Alfa Scientific Designs, Inc.	2002-11-13	107
K022141	VERDICT-II	Medtox Diagnostics, Inc.	2002-07-30	28
K011185	PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY	Psychemedics Corp.	2002-01-24	281
K013180	RAPIDONE-ECSTASY TEST	American Bio Medica Corp.	2001-11-26	63
K010226	VERDICT -II METHAMPHETAMINE	Medtox Diagnostics, Inc.	2001-06-01	128
K002265	BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCR	Branan Medical Corporation	2000-11-27	125
K002587	BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG	Branan Medical Corporation	2000-11-22	93
K994406	INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST	Alfa Scientific Designs, Inc.	2000-08-14	230
K994400	INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2000-08-04	220
K001356	ONTRAK TESTCUP PRO-5, MODEL 1986678	Roche Diagnostics Corp.	2000-07-10	73
K993100	REDI-SCREEN	Redwood Biotech, Inc.	1999-10-06	20
K781156	DIALYSIS SYS., PDS 400 & RO 400	Physio-Control Corp.	1978-10-24	105
K781153	KIDNEY, ARTIFICIAL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-10-17	99
K781140	CUTTER RESIFLEX FOLEY CATHETERS	Cutler Laboratories, Inc.	1978-09-07	17
K781237	KIDNEY, ARTIFICIAL, C-DAK 2.0	Cordis Corp.	1978-08-31	42
K781238	KIDNEY, ARTIFICIAL, C-DAK 1.5	Cordis Corp.	1978-08-31	42
K781110	BANDAGE, COMPRESSION, FISTULAID	Medical Device Laboratories	1978-08-18	46
K781331	A-V FISTULA NEEDLE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-08-17	15

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