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

LGQ — Predicate Candidate Screening

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

39 daysmedian FDA review time

126 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K972331	INNOFLUOR GENTAMICIN ASSAY SYSTEM	Oxis Intl., Inc.	1997-08-01	39
K972330	INNOFLUOR PHENOBARBITAL ASSAY SYSTEM	Oxis Intl., Inc.	1997-07-14	21
K940596	AXSYM PHENOBARBITAL	Abbott Laboratories	1994-06-21	131
K936130	COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITA	Roche Diagnostic Systems, Inc.	1994-03-11	78
K900704	MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA	Innotron of Oregon, Inc.	1990-04-12	59
K894525	FPR PHENOBARBITAL KIT	Colony Laboratories, Inc.	1989-08-28	39
K872397	COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.	Roche Diagnostic Systems, Inc.	1987-07-21	29
K863625	PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT	Windsor Laboratories, Inc.	1986-11-10	54
K862528	IMMPULSE PHENOBARBITAL ASSAY REAGENTS	Sclavo, Inc.	1986-07-16	14
K854044	TDX BARBITURATES	Abbott Laboratories	1985-10-28	26
K843825	COBAS REAGENTS PHENOBARBITAL & PHENOBAR	Roche Diagnostic Systems, Inc.	1985-02-01	126
K841707	INNOFLUOR PHENOBARBITAL	Innotron Diagnostics	1984-05-23	30

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