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

NBC — Predicate Candidate Screening

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

112 daysmedian FDA review time

360 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252169	Access BNP II	Beckman Coulter, Inc.	2026-03-24	257	0
K253539	Alere NT-proBNP for Alinity i	Axis-Shield Diagnostics, Ltd.	2026-02-18	97	0
K241176	Alere NT-proBNP for Alinity i Reagent Kit	Axis-Shield Diagnostics, Ltd.	2025-01-16	262	0
K232164	Access NT-proBNP	Beckman Coulter, Inc.	2024-04-12	266	0
K220265	ADVIA Centaur® NT-proBNPII (PBNPII)	Siemens Healthcare Diagnostics, Inc.	2023-09-24	601	0
K223637	Elecsys proBNP II, Elecsys proBNP II STAT	Roche Diagnostics	2023-07-21	228	0
K210546	Elecsys proBNP II, Elecsys proBNP II STAT	Roche Diagnostics	2022-03-31	399	0
K211199	ST AIA-PACK BNP Assay	Tosoh Bioscience, Inc.	2021-11-08	200	0
K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack	Ortho Clinical Diagnostics	2021-10-04	504	0
K192380	ST AIA-PACK BNP	Fujirebio Diagnostics,Inc.	2020-08-24	360	0
K092649	ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CAL	Roche Diagnostics Corp.	2010-02-04	160	0
K082645	DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP)	Siemens Healthcare Diagnostics	2008-09-22	11	1
K063662	RAMP NT-PROBNP ASSAY	Response Biomedical Corp.	2008-07-21	591	0
K080269	TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS	Biosite Incorporated	2008-06-06	126	4
K080578	DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PB	Siemens Healthcare Diagnostics, Inc.	2008-05-16	74	0
K073091	VIDAS NT-PROBNP ASSAY, MODEL: 30 449	bioMerieux, Inc.	2008-02-29	120	1
K072437	ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET	Roche Diagnostics	2008-02-05	166	0
K072189	PATHFAST NTPROBNP AND D-DIMER TESTS	Mitsubishi Kagaku Iatron	2008-02-05	183	0
K071834	STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM	Dade Behring, Inc.	2007-08-17	45	2
K071767	DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A	Dade Behring, Inc.	2007-08-04	36	0
K061795	DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR	Dade Behring, Inc.	2006-09-11	80	0
K053597	I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)	I-Stat Corporation	2006-07-21	210	2
K060632	VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CAL	Ortho-Clinical Diagnostics, Inc.	2006-06-06	89	0
K060964	ARCHITECT BNP ASSAY, MODEL 8K28	Fujirebio Diagnostics,Inc.	2006-05-25	48	0
K051596	STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL	Nanogen, Inc.	2006-03-13	270	0
K052789	TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MOD	Biosite Incorporated	2006-01-23	112	1
K051382	ELECSYS PROBNP IMMUNOASSAY	Roche Diagnostics Corp.	2005-12-05	192	0
K051787	TRIAGE BNP TEST, MODEL 98000XR	Biosite Incorporated	2005-09-22	83	0
K051265	ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE	Bayer Healthcare, LLC	2005-06-13	28	0
K043228	ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) A	Bayer Healthcare, LLC	2005-04-22	151	0
K043476	STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRA	Dade Behring, Inc.	2005-02-15	61	2
K042347	MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE M	Dade Behring, Inc.	2004-11-19	81	0
K041417	DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION	Dade Behring, Inc.	2004-07-20	54	0
K040425	ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) A	Bayer Healthcare, LLC	2004-06-14	117	0
K033606	ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE	Axis-Shield Diagnostics, Ltd.	2004-01-30	74	0
K032235	MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2004-01-28	191	0
K033383	TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS,	Biosite Incorporated	2003-12-23	61	0
K032646	ELECSYS PROBNP IMMUNOASSAY	Roche Diagnostics Corp.	2003-11-12	77	0
K032525	BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	Bayer Healthcare, LLC	2003-09-09	25	0
K031038	ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY	Bayer Healthcare, LLC	2003-06-23	83	5
K030286	TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL	Biosite Incorporated	2003-02-21	24	3
K022516	ELECSYS PROBNP IMMUNOASSAY	Roche Diagnostics Corp.	2002-11-19	112	0
K021317	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2002-07-01	67	0
K010266	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000	Biosite Incorporated	2001-03-16	46	0
DEN000010	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	Biosite Incorporated	2000-11-20	5	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