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

OZZ — Predicate Candidate Screening

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

90 daysmedian FDA review time

350 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243753	cobas liat Bordetella panel nucleic acid test	Roche Molecular Systems, Inc.	2025-11-20	350	0
K183223	Simplexa Bordetella Direct, Simplexa Bordetella Positive Con	Diasorin Molecular, LLC	2018-12-19	29	0
K173498	Simplexa Bordetella Direct, Simplexa Bordetella Positive Con	Diasorin Molecular, LLC	2018-08-13	273	0
K181029	Solana Bordetella Complete Assay	Quidel Corporation	2018-07-15	88	1
K163626	ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File	Luminex Corporation	2017-05-02	131	1
K170284	Great Basin Bordetella Direct Test	Great Basin Scientific, Inc.	2017-03-31	60	0
K152285	illumigene Pertussis DNA Amplification Assay	Meridian Bioscience, Inc.	2015-11-10	90	0
K143206	AmpliVue Bordetella Assay	Quidel Corporation	2014-12-10	33	0
K133673	ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERT	Meridian Bioscience, Inc.	2014-03-25	116	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