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

LGS — Predicate Candidate Screening

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

59 daysmedian FDA review time

98 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K070810	ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)	Biokit, S.A.	2007-06-08	74
K955567	INNOFLUOR THEOPHYLLINE ASSAY SYSTEM	Oxis Intl., Inc.	1996-01-24	49
K953016	AXSYM THEOPHYLLINE II	Abbott Laboratories	1995-08-24	56
K951169	CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1995-06-20	97
K942991	QMS THEOPHYLLINE CS	Seradyn, Inc.	1994-09-09	81
K932127	TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II	Abbott Laboratories	1993-08-09	98
K922991	ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE	Abbott Laboratories	1992-08-27	66
K900706	MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA	Innotron of Oregon, Inc.	1990-04-12	59
K894529	FPR THEOPHYLLINE KIT	Colony Laboratories, Inc.	1989-09-15	57
K871484	COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS	Roche Diagnostic Systems, Inc.	1987-05-28	43
K870277	MONITORX LASERX THEOPHYLLINE REAGENT SET	American Monitor Corp.	1987-02-18	22
K850629	INNOFLUOR THEOPHYLLINE	Innotron Diagnostics	1985-03-12	21
K843826	COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL	Roche Diagnostic Systems, Inc.	1985-02-01	126

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