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

PGX · Predicate Candidate Screening

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

92 daysmedian FDA review time

181 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260333	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control	Diasorin Molecular, LLC	2026-06-15	133	0
K201269	Accula Strep A Test	Mesa Biotech, Inc.	2020-11-09	181	0
K183366	GenePOC Strep A	Genepoc, Inc.	2019-03-06	92	0
K173653	Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Con	Alere Scarborough, Inc.	2018-05-02	155	0
K173398	Xpert Xpress Strep A	Cepheid	2018-04-26	177	0
K172402	ARIES Group A Strep Assay, ARIES Group A Strep Assay Protoco	Luminex Corporation	2017-10-30	82	1
K172126	Xpert Xpress Strep A	Cepheid	2017-09-25	73	2
K162274	Solana Strep Complete Assay	Quidel Corporation	2016-10-25	74	0
K150868	Solana GAS Assay, Solana instrument	Quidel Corporation	2015-06-23	83	0
K141757	ALERE I STREP A	Alere Scarborough, Inc.	2015-03-31	274	0
K143651	Simplexa Group A Strep Direct, Simplexa Group A Strep Positi	Focus Diagnostics, Inc.	2015-03-18	85	1
K141338	LIAT STREP A ASSAY	Iquum, Inc.	2014-11-04	167	0
K141173	AMPLIVUE GAS ASSAY	Quidel Corporation	2014-07-24	79	0
DEN140005	LYRA DIRECT STREP ASSAY	Quidel Corporation	2014-04-16	22	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