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

GQG — Predicate Candidate Screening

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

93 daysmedian FDA review time

175 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253318	Clungene RSV Antigen Rapid Test	Hangzhou Clongene Biotech Co., Ltd.	2026-01-30	122	0
K240280	Nano-Check™ RSV Test	Nano-Ditech Corporation	2024-07-30	180	0
K162911	Sofia RSV FIA on Sofia 2 analyzer	Quidel Corporation	2017-02-22	128	0
K133140	BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV	Becton, Dickinson & CO	2013-11-15	29	0
K132456	BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV	Becton, Dickinson and Company	2013-11-07	93	0
K130398	SOFIA(R) RSV FIA	Quidel Corp.	2013-08-13	175	0
K121633	BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV	Becton, Dickinson and Company	2012-09-18	106	0
K101918	QUICKVUE RSV 10	Quidel Corp.	2010-09-24	77	0
K101514	BD DIRECTIGEN EZ RSV	Becton, Dickinson & CO	2010-07-09	37	0
K091235	RAMP RSV ASSAY	Response Biomedical Corp.	2009-07-24	88	0
K070747	QUICK VUE RSV TEST, MODELS 20193, 20199	Quidel Corp.	2007-04-23	35	0
K041445	IMMUNOCARD STAT! RSV MODEL #750630	Meridian Bioscience, Inc.	2004-08-13	73	0
K032166	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGE	Binax, Inc.	2003-10-21	97	2
K022845	SAS RSV TEST	Sa Scientific, Inc.	2003-01-29	155	0
K023779	RSV OIA	Thermo Biostar, Inc.	2003-01-14	63	0
K022133	BD DIRECTIGEN EZ RSV KIT	Becton, Dickinson & CO	2002-12-10	162	1
K021789	QUICKLAB RSV	Integrated Biotechnology Corp.	2002-11-20	173	0
K021687	BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB	Binax, Inc.	2002-09-13	114	0
K964870	RSV ANTIGEN CONTROL SLIDES	Viral Antigens, Inc.	1997-03-18	103	0
K896097	VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY	Vitek Systems, Inc.	1990-02-26	129	0
K884516	FITC MURINE MONOCLONAL ANTI-RSV IGG	Whittaker Bioproducts, Inc.	1989-01-13	78	0
K882629	DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-10-31	126	0
K882277	ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL	Abbott Laboratories	1988-06-22	22	0
K874127	ABBOTT TESTPACK RSV	Abbott Laboratories	1988-05-06	206	0
K862743	PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS	Kallestad Laboratories, Inc.	1986-09-29	70	0
K862429	ABBOTT RSV EIA	Abbott Laboratories	1986-09-16	82	0
K854081	IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST	Boots-Celltech Diagnostics, Inc.	1986-01-03	88	0
K853695	RESPIRATORY SYNCYTIAL VIRUS ID REAGENT	Viromed Laboratories, Inc.	1985-12-04	91	0
K843673	RESPIRATORY SYNCYTIAL VIRUS	Institute Virion , Ltd.	1985-09-26	374	0
K802936	RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &	Orion Diagnostica, Inc.	1980-12-31	42	0
K770808	RESP. SYNCYTIAL-FA LABELLED PRESERUM	Flow Laboratories, Inc.	1977-05-20	17	0
K770804	RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)	Flow Laboratories, Inc.	1977-05-20	17	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