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

OQO — Predicate Candidate Screening

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

96 daysmedian FDA review time

191 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172509	Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc.	2018-02-01	164	0
K162673	Aptima Herpes Simplex Viruses 1 & 2 Assay	Hologic, Inc.	2017-06-15	262	0
K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Contr	Focus Diagnostics	2015-08-28	140	2
K150617	cobas HSV 1 and 2 Test	Roche Molecular Systems, Inc.	2015-06-01	83	0
K142156	SEEGENE ANYPLEX II HSV-1/2 ASSAY	Seegene	2015-02-13	191	0
K142738	artus HSV-1/2 QS-RGQ MDx Kit	Qiagen	2014-12-19	87	0
K140198	IMDX HSV-1/2 FOR ABBOTT M2000	Intelligent Medical Devices, Inc.	2014-05-13	106	0
K140029	AMIPLIVUE HSV 1&2 ASSAY	Quidel Corporation	2014-03-26	79	0
K111951	ISOAMP HSV ASSAY	Biohelix Corporation	2011-09-27	81	0
K111527	MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT	Eragen Biosciences, Inc.	2011-08-03	63	0
K103798	BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DN	Becton, Dickinson & CO	2011-03-18	81	0
K100336	MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711	Eragen Biosciences	2010-05-12	96	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