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

DKE · Predicate Candidate Screening

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

52 daysmedian FDA review time

157 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K003687	VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II	Medtox Diagnostics, Inc.	2000-12-22	22
K994405	INSTANT-VIEW MARIJUANA URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2000-06-02	157
K992068	STATUS STIK, ACCUSIGN STIK	Princeton BioMeditech Corp.	1999-07-06	18
K991751	STATUS CUP ACCUSIGN CUP	Princeton BioMeditech Corp.	1999-06-18	25
K991078	ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP,	Princeton BioMeditech Corp.	1999-04-15	20
K983147	ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/A	Princeton BioMeditech Corp.	1998-09-28	20
K982211	PROFILE-II MODEL 600582	Medtox Diagnostics, Inc.	1998-07-29	36
K901694	SPEC(TM) EXTRACTION CARTRIDGE	Toxi-Lab, Inc.	1990-06-01	52
K875182	MODIFIED LABELING FOR TOXI-LAB THC SCREEN	Marion Laboratories, Inc.	1988-07-05	201
K841831	CANNU-SKREEN-PRELIMINARY	Biochemical Diagnostic, Inc.	1984-07-06	64
K831456	TOXI-LAB CANNABINOID THC SCREEN	Marion Laboratories, Inc.	1983-06-30	55
K792282	DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG	California Medical Developments, Inc.	1980-02-29	108

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