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

Quidel Corporation — Predicate Candidate Screening

37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

265 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231795	QuickVue COVID-19 Test	Quidel Corporation	2024-03-22	276	0
K232286	Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set,	Quidel Corporation	2023-12-20	141	0
K233688	Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control	Quidel Corporation	2023-12-13	26	0
K230349	Lyra RSV+hMPV Assay	Quidel Corporation	2023-03-10	29	0
DEN220039	Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control	Quidel Corporation	2023-03-08	265	0
K230236	Lyra Influenza A+B Assay	Quidel Corporation	2023-03-03	32	0
K211342	Sofia 2 Campylobacter FIA	Quidel Corporation	2021-11-23	204	0
K173496	Sofia 2 Lyme FIA, Sofia Lyme Control Set	Quidel Corporation	2018-08-30	290	0
K181029	Solana Bordetella Complete Assay	Quidel Corporation	2018-07-15	88	1
K173691	Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack	Quidel Corporation	2018-02-28	89	0
K180288	QuickVue Influenza A+B	Quidel Corporation	2018-02-13	12	0
K173250	Solana GBS Assay	Quidel Corporation	2017-12-21	72	0
K171976	Sofia Strep A+ FIA, Sofia 2 Analyzer	Quidel Corporation	2017-12-21	174	0
K163713	Sofia Lyme FIA, Sofia Lyme Control Set	Quidel Corporation	2017-10-20	294	0
K171974	Solana RSV+hMPV Assay	Quidel Corporation	2017-10-16	108	0
K170491	Solana C. difficile Assay	Quidel Corporation	2017-05-11	83	0
K162438	Sofia Influenza A+B FIA on Sofia 2	Quidel Corporation	2017-04-14	226	0
K162911	Sofia RSV FIA on Sofia 2 analyzer	Quidel Corporation	2017-02-22	128	0
K162451	Solana HSV 1+2/VZV Assay	Quidel Corporation	2016-11-28	88	0
K162274	Solana Strep Complete Assay	Quidel Corporation	2016-10-25	74	0
K161814	Solana Influenza A+B Assay	Quidel Corporation	2016-09-27	88	0
K161182	Solana Trichomonas Assay	Quidel Corporation	2016-08-15	110	0
K153012	Sofia Influenza A+B FIA	Quidel Corporation	2016-01-12	90	0
K150868	Solana GAS Assay, Solana instrument	Quidel Corporation	2015-06-23	83	0
K143329	AmpliVue Trichomonas Assay	Quidel Corporation	2015-03-17	117	0
K141775	SOFIA (R) STREP A+ FIA	Quidel Corporation	2014-12-16	168	1
K143206	AmpliVue Bordetella Assay	Quidel Corporation	2014-12-10	33	0
K141927	LYRA PARAINFLUENZA VIRUS ASSAY	Quidel Corporation	2014-10-09	85	0
K141931	LYRA ADENOVIRUS ASSAY	Quidel Corporation	2014-10-09	85	0
K141173	AMPLIVUE GAS ASSAY	Quidel Corporation	2014-07-24	79	0
DEN140005	LYRA DIRECT STREP ASSAY	Quidel Corporation	2014-04-16	22	0
K140029	AMIPLIVUE HSV 1&2 ASSAY	Quidel Corporation	2014-03-26	79	0
K133503	AMPLIVUE GBS ASSAY	Quidel Corporation	2013-12-20	36	0
K131599	QUICK VUE INFLUENZA	Quidel Corporation	2013-07-05	32	0
K123793	SOFIA STREP A FIA	Quidel Corporation	2013-06-17	189	0
K123355	AMPLIVUE C. DIFFICILE ASSAY	Quidel Corporation	2012-12-13	43	0
K102175	RAPIDVUE HCG TEST	Quidel Corporation	2010-08-25	23	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