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

GMZ — Predicate Candidate Screening

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

148 daysmedian FDA review time

238 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222829	Curian® Shiga Toxin	Meridian Bioscience, Inc.	2023-04-17	210	0
K121411	SHIGA TOXIN CHEK	Techlab Inc., Corporate Research Center	2012-10-02	144	0
K121364	SHIGA TOXIN QUIK CHEK	Techlab Inc., Corporate Research Center	2012-10-02	148	0
K062546	IMMUNOCARD STAT! EHEC, MODEL 751630	Meridian Bioscience, Inc.	2007-02-14	168	0
K061889	BIOSTAR OIA SHIGATOX	Inverness Medical-Biostar, Inc.	2006-12-12	162	1
K023599	IMMUNOCARD STAT! E. COLI O157 PLUS	Meridian Bioscience, Inc.	2003-01-03	67	0
K990263	IMMUNOCARD STAT! E. COLI O157:H7	Meridian Diagnostics, Inc.	1999-08-09	194	0
K980507	PROSPECT SHIGA TOXIN MICROPLATE ASSAY	Alexon - Trend, Inc.	1998-04-23	72	1
K973457	CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800	Shared Systems, Inc.	1998-01-02	112	0
K971663	WELLCOLEX E.COLI O157:H7	Murex Biotech , Ltd.	1997-12-30	238	0
K972156	QUIX RAPID E. COLI O157 STRIP TEST	Guardian Scientific, Corp.	1997-10-16	129	0
K942705	E. COLI 0157 ELISA STOOL ASSAY	Lmd Laboratories	1995-09-27	476	0
K944421	E.COLI 0157 LATEX TEST	Pro-Lab Diagnostics	1994-12-15	119	0
K884513	PF TEST	Medi-Tech, Inc.	1989-02-03	99	0

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