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

DDR — Predicate Candidate Screening

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

56 daysmedian FDA review time

173 days90th percentile

46clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231832	Access Myoglobin	Beckman Coulter, Inc.	2023-09-18	88	0
K123785	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	Diazyme Laboratories	2013-06-07	179	0
K122599	ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN	Siemens Healthcare Diagnostics, Inc.	2012-10-03	37	0
K083260	ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN	Roche Diagnostics	2009-10-16	345	0
K080481	ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY	Beckman Coulter, Inc.	2009-02-20	364	0
K061683	TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM	Roche Diagnostics Corp.	2006-07-21	36	0
K042924	ARCHITECT STAT MYO IMMUNOASSAY	Fisher Diagnostics	2005-01-24	94	1
K042982	QUANTEX MYOGLOBIN	Instrumentation Laboratory CO	2004-12-22	54	0
K033300	VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CAL	Ortho-Clinical Diagnostics, Inc.	2003-11-05	22	0
K021229	MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSA	Beckman Coulter, Inc.	2002-06-28	71	1
K012040	RAMP MYOGLOBIN ASSAY	Response Biomedical Corp.	2001-12-18	172	0
K010700	RANDOX MYOGLOBIN	Randox Laboratories, Ltd.	2001-05-08	61	0
K000196	ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS	Beckman Coulter, Inc.	2000-02-18	28	0
K992976	K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR	Kamiya Biomedical Co.	1999-11-01	59	0
K991796	IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5	Diagnostic Products Corp.	1999-06-09	14	0
K991277	MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5	Diagnostic Products Corp.	1999-04-27	13	0
K984145	OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT	Olympus Diagnostica GmbH	1998-12-23	34	0
K984065	STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK	Dade Behring, Inc.	1998-12-14	28	2
K984191	MYOGLOBIN FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	1998-12-10	17	0
K983970	IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5	Diagnostic Products Corp.	1998-11-25	16	0
K983848	ABBOTT AXSYM MYOGLOBIN	Abbott Laboratories	1998-11-16	17	2
K982679	MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST	Spectral Diagnostics, Inc.	1998-10-07	68	0
K983176	ELECSYS MYOGLOBIN STAT ASSAY	Boehringer Mannheim Corp.	1998-09-24	14	0
K981012	AIA-PACK MYOGLOBIN ASSAY	Tosoh Medics, Inc.	1998-05-28	71	0
K981102	STRATUS CS MYOGLOBIN (MYO) TESTPAK	Dade Behring, Inc.	1998-04-27	32	0
K974325	CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN	Chiron Diagnostics Corp.	1997-12-08	20	0
K972513	TINAQUANT MYOGLOBIN ASSAY	Boehringer Mannheim Corp.	1997-07-28	21	0
K965213	STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY	Dade Intl., Inc.	1997-02-10	42	0
K963680	TARGET MYOGLOBIN TEST	Texas Immunology, Inc.	1997-02-06	143	0
K962344	MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO	Bayer Corp.	1996-08-15	58	0
K951634	ACCESS MYOGLOBIN REAGENTS	Bio-Rad Laboratories, Inc.	1995-09-27	173	0
K952360	CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGL	Princeton BioMeditech Corp.	1995-08-14	103	0
K942052	LIFESIGN MI MYOGLOBIN	Princeton Biomedix	1995-02-07	285	0
K923195	MYOGLOBIN ELISA TEST KIT	Immuno Diagnostic Center, Inc.	1992-11-06	129	0
K922125	STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY	Baxter Diagnostics, Inc.	1992-07-21	76	0
K922387	DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL	Baxter Diagnostics, Inc.	1992-07-15	56	0
K915233	MYOGLOBIN RIA TEST KIT	Pro Diagnostics, Inc.	1992-03-30	129	0
K915850	OPUS MYOGLOBIN TEST SYSTEM	Pb Diagnostic Systems, Inc.	1992-03-17	82	0
K905202	TURBIQUANT MYOGLOBIN	Behring Diagnostics, Inc.	1990-12-13	23	0
K903687	TURBIQUANT MYOGLOBIN	Behring Diagnostics, Inc.	1990-10-16	62	0
K904038	MYOGLOBIN RIA TEST KIT	Immuno Diagnostic Center, Inc.	1990-09-24	20	0
K902154	NA LATEX MYOGLOBIN TEST	Behring Diagnostics, Inc.	1990-06-01	17	0
K863730	MYOLEX	Orion Corp.	1986-10-15	22	0
K780982	KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT	Cis Radiopharmaceuticals, Inc.	1978-06-22	8	0
K772095	HEMAGGLUTINATION INHIBITION TEST	Miles Laboratories, Inc.	1978-01-05	59	0
K771242	ANTISERA TO HUMAN FAB FRAGMENT	Kent Laboratories, Inc.	1977-08-03	23	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