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

MRR — Predicate Candidate Screening

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

72 daysmedian FDA review time

273 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241800	Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Choles	Siemens Healthcare Diagnostics, Inc.	2024-07-26	35	0
K210801	AXINON® LDL-p Test System	Numares AG	2023-07-19	854	0
K161691	Direct LDL Cholesterol (LDL)	Randox Laboratories Limited	2017-03-20	273	0
K091333	S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022	Alfa Wassermann, Inc.	2009-08-03	89	0
K090734	EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTRO	Medica Corp.	2009-07-17	120	0
K063841	NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS	Liposcience	2008-07-23	575	0
K051121	DIRECT LDL CHOLESTEROL, MODEL L530-60H	Teco Diagnostics	2005-08-08	98	0
K043264	LDL-EX SEIKEN ASSAY KIT	Denka Seiken Co., Ltd.	2005-01-26	63	0
K041927	LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40	Diagnostic Chemicals , Ltd.	2004-11-23	127	0
K041720	VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, F	Ortho-Clinical Diagnostics, Inc.	2004-08-25	62	0
K040693	PTS PANELS LDL CHOLESTEROL TEST STRIPS	Polymer Technology Systems, Inc.	2004-07-06	111	1
K022772	RAICHEM LDL-CHOLESTEROL DIRECT REAGENT	Hemagen Diagnostics, Inc.	2002-09-17	27	0
K020724	DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE ME	Dade Behring, Inc.	2002-05-09	64	0
K020575	ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS	Elan Diagnostics	2002-04-12	50	0
K014103	SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRAT	Beckman Coulter, Inc.	2002-01-28	46	1
K012287	MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENE	Roche Diagnostics Corp.	2001-08-07	18	2
K993741	EZ LDL CHOLESTEROL TEST SYSTEM	Sigma Diagnostics, Inc.	2000-07-03	242	0
K992766	N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLE	Genzyme Corp.	1999-10-18	62	0
K991733	ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS	Schiapparelli Biosystems, Inc.	1999-07-13	53	0
K984107	RDI DIRECT LDL CHOLESTEROL TEST	Reference Diagnostics, Inc.	1999-01-28	72	0
K982848	COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR L	Roche Diagnostic Systems, Inc.	1998-10-01	50	0
K982271	WAKO DIRECT LDL-C	Wako Chemicals USA, Inc.	1998-09-22	85	0
K982529	RANDOX DIRECT LDL CHOLESTEROL	Randox Laboratories, Ltd.	1998-09-11	53	1
K981303	DIRECT LDL	Abbott Laboratories	1998-08-03	115	0
K981978	AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALI	Pointe Scientific, Inc.,	1998-07-22	47	0
K964063	RDI LDL PRECIPITATION REAGENT	Reference Diagnostics, Inc.	1996-11-20	41	0
K964064	RDI LIPIDIRECT MAGNETIC LDL REAGENT	Reference Diagnostics, Inc.	1996-11-20	41	0
K955904	EKTACHEM DT LDL CHOLESTEROL KIT	Johnson & Johnson Clinical Diagnostics, Inc.	1996-05-24	147	0
K943150	DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT	Genzyme Corp.	1995-03-15	258	0
K924674	DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT	Genzyme Corp.	1993-01-06	112	0
K893740	LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES	Reference Diagnostics, Inc.	1990-03-19	306	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