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

JXN — Predicate Candidate Screening

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

69 daysmedian FDA review time

154 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K152495	Wondfo Propoxyphene Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	2015-11-23	83
K122752	FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN	Branan Medical Corp.	2013-01-30	145
K111363	PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL	Medica Corp.	2011-12-06	204
K043303	ONLINE DAT PROPOXYPHENE PLUS	Roche Diagnostics Corp.	2005-03-11	101
K040445	ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP	ACON Laboratories, Inc.	2004-05-19	89
K030835	'RAPID ONE' - PROPOXYPHENE TEST	American Bio Medica Corp.	2003-05-22	66
K023795	PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT	Lin-Zhi International, Inc.	2003-01-21	69
K022915	INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST	Alfa Scientific Designs, Inc.	2002-11-29	87
K020787	VERDICT-II PROPOXYPHENE	Medtox Diagnostics, Inc.	2002-05-02	52
K013100	PROPOXYPHENE	Abbott Laboratories	2002-03-20	184
K011163	MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL O	Syva Co., Dade Behring, Inc.	2001-05-10	24
K993981	SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL	Syva Co.	2000-02-01	69
K983700	MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE	Roche Diagnostic Systems, Inc.	1998-12-11	51
K955675	SYNCHRON SYSTEMS PROPOXYPHENE REAGENT	Beckman Instruments, Inc.	1996-02-09	56
K951133	CEDIA DAU PROPOXYPHENE ASSAY	Microgenics Corp.	1995-05-02	50
K944372	STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA	Solarcare, Inc.	1995-02-08	154
K945195	ABUSCREEN ONLINE PROPOXPHENE	Roche Diagnostic Systems, Inc.	1994-12-09	46
K943414	PROPOXPHENE EIA TEST	Diagnostic Reagents, Inc.	1994-09-09	56
K923873	SYVA EMIT II PROPOXYPHENE ASSAY	Syva Co.	1992-11-02	91
K912365	TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS	Abbott Laboratories	1991-08-16	79
K874200	REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS	Syva Co.	1987-10-28	14
K850920	EMIT D.A.U. PROPOXYPHENE ASSAY	Syva Co.	1985-04-02	28

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