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

LBR — Predicate Candidate Screening

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

59 daysmedian FDA review time

137 days90th percentile

66clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143691	LDLC3 LDL-Cholesterol Gen.3	Roche Diagnostics Operations (Rdo)	2015-01-28	35	0
K072523	DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS	General Atomics	2008-01-22	137	0
K050823	DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR	Teco Diagnostics	2005-07-26	117	0
K023784	RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBE	Hemagen Diagnostics, Inc.	2002-12-24	42	0
K012593	VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT,	Ortho-Clinical Diagnostics, Inc.	2001-08-30	20	1
K992029	ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATO	Elan Diagnostics	1999-08-12	57	0
K992002	AUTOHDL CHOLESTEROL REAGENT SET	Pointe Scientific, Inc.,	1999-08-05	51	12
K991789	ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIB	Elan Holdings, Inc.	1999-07-09	45	0
K990247	MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470	Polymer Technology Systems, Inc.	1999-05-28	122	0
K984303	VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT	Ortho-Clinical Diagnostics, Inc.	1999-01-28	57	0
K980772	HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-	Diagnostic Chemicals , Ltd.	1998-04-27	66	0
K980770	HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51	Diagnostic Chemicals , Ltd.	1998-04-21	60	0
K974733	BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL	Boehringer Mannheim Corp.	1998-01-26	39	1
K973369	ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)	Roche Diagnostic Systems, Inc.	1997-11-21	74	0
K971573	N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL	Genzyme Corp.	1997-06-18	49	0
K962723	TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN	Trace America, Inc.	1997-03-13	241	0
K962186	N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR	Genzyme Corp.	1996-08-19	74	0
K954179	HDL PRECIPITATING REAGENT	Schiapparelli Biosystems, Inc.	1995-12-11	96	0
K944975	MAGNETIC HDL CHOLESTEROL TEST	Reference Diagnostics, Inc.	1995-08-02	295	0
K941744	PBI PLUS HDL PRECIPITATING REAGENT	Merchant House Scientific	1994-09-06	152	0
K932766	HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)	Diagnostic Chemicals, Ltd. (Usa)	1993-12-10	185	0
K934961	SPINPRO HDL PRECIPITATING REAGENT	Merchant House Scientific	1993-12-09	55	0
K934801	SPINPRO HDL PRECIPITATING REAGENT	Merchant House Scientific	1993-12-07	61	0
K934039	INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET	Intersect Systems, Inc.	1993-11-16	90	0
K931773	HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)	King Diagnostics, Inc.	1993-08-16	129	0
K924427	SYNERMED HDL CHOLESTLEROL REAGENT KIT	Synermed, Inc.	1992-11-09	69	0
K914811	IL TEST(TM) HDL CHOLESTEROL	Instrumentation Laboratory CO	1992-01-09	76	0
K912823	HIGH DENSITY LIPOPROTEIN CHOLESTEROL	Creative Laboratory Products, Inc.	1991-08-16	51	0
K911906	MAGNETIC HDL CHOLESTEROL TEST	Reference Diagnostics, Inc.	1991-07-18	79	0
K911406	HDL CHOLESTEROL REAGENT	Genzyme Corp.	1991-05-22	54	0
K903733	ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM	Institute For Clinical Applications	1991-01-15	152	0
K905284	HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173	Amresco, Inc.	1990-12-11	18	0
K904184	BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT	Biotron U.S.A., Inc.	1990-11-28	77	0
K903094	STAT TEST HDL/CHOLESTEROL TEST KIT	Diagnostic Resources, Inc.	1990-08-29	47	0
K902568	REFLOTRON HDL CHOLESTEROL TEST TABS	Boehringer Mannheim Corp.	1990-08-09	59	0
K902174	COULTER HDL - CHOLESTEROL REAGENT	Coulter Corp.	1990-07-31	78	0
K900120	ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL	Roche Diagnostic Systems, Inc.	1990-03-09	59	0
K895381	HDL SINGLES	Trace America, Inc.	1989-11-08	71	0
K893966	HDL PRECIPITATING REAGENT	Diagnostic Systems	1989-07-25	53	0
K891117	HDL CHOLESTEROL REAGENT	Pointe Scientific, Inc.,	1989-04-10	39	0
K890669	STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE	Norfolk Scientific, Inc.	1989-03-08	27	0
K890023	HDL CHOLESTEROL REAGENT (PTA/MGCL2)	Sigma Diagnostics, Inc.	1989-02-17	44	0
K885265	HDL CHOLESTEROL TEST	Em Diagnostic Systems, Inc.	1989-02-10	50	0
K883353	IQ HDL CHOLESTEROL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-09-13	35	0
K882488	CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES	Canyon Diagnostics, Inc.	1988-08-15	60	0
K881244	HDL CHOLESTEROL KIT	Trace Scientific , Ltd.	1988-06-10	79	0
K881326	HDL CHOLESTEROL PRECIPITATING PROCEDURE	Data Medical Associates, Inc.	1988-05-27	59	0
K880176	HDL CHOLESTEROL PRECIPITATING REAGENT	Tech-Co, Inc.	1988-02-18	34	0
K874820	MULTICHEM HDL PRECIPITATING REAGENT #S0914	Simmler, Inc.	1988-01-07	44	0
K861926	WORTHINGTON HDL PRECIPITATING REAGENT SET	Cooper Biomedical, Inc.	1986-06-27	39	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