Product Code: DDR FDA class 2 21 CFR 866.5680

Myoglobin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring myoglobin, an oxygen-storage protein in muscle tissue that is released into the circulation following ischemic or traumatic muscle injury, including antigen, antiserum, and control components for clinical immunoassay testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDR, regulated under 21 CFR 866.5680, within the Immunology specialty.

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Basic Information

Product Code: DDR
Device Class: FDA class 2
Regulation Number: 866.5680
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231832	Access Myoglobin	Sep 18, 2023	Substantially Equivalent	Beckman Coulter, Inc.
K123785	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	Jun 07, 2013	Substantially Equivalent	Diazyme Laboratories
K122599	ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR	Oct 03, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K083260	ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN	Oct 16, 2009	Substantially Equivalent	Roche Diagnostics
K080481	ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS	Feb 20, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K061683	TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM	Jul 21, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K042924	ARCHITECT STAT MYO IMMUNOASSAY	Jan 24, 2005	Substantially Equivalent	Fisher Diagnostics
K042982	QUANTEX MYOGLOBIN	Dec 22, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K033300	VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS	Nov 05, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K021229	MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244	Jun 28, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K012040	RAMP MYOGLOBIN ASSAY	Dec 18, 2001	Substantially Equivalent	Response Biomedical Corp.
K010700	RANDOX MYOGLOBIN	May 08, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K000196	ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316	Feb 18, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K992976	K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR	Nov 01, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991796	IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5	Jun 09, 1999	Substantially Equivalent	Diagnostic Products Corp.
K991277	MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5	Apr 27, 1999	Substantially Equivalent	Diagnostic Products Corp.
K984145	OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT	Dec 23, 1998	Substantially Equivalent	Olympus Diagnostica GmbH
K984065	STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK	Dec 14, 1998	Substantially Equivalent	Dade Behring, Inc.
K984191	MYOGLOBIN FLEX REAGENT CARTRIDGE	Dec 10, 1998	Substantially Equivalent	Dade Behring, Inc.
K983970	IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5	Nov 25, 1998	Substantially Equivalent	Diagnostic Products Corp.
K983848	ABBOTT AXSYM MYOGLOBIN	Nov 16, 1998	Substantially Equivalent	Abbott Laboratories
K982679	MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST	Oct 07, 1998	Substantially Equivalent	Spectral Diagnostics, Inc.
K983176	ELECSYS MYOGLOBIN STAT ASSAY	Sep 24, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K981012	AIA-PACK MYOGLOBIN ASSAY	May 28, 1998	Substantially Equivalent	Tosoh Medics, Inc.
K981102	STRATUS CS MYOGLOBIN (MYO) TESTPAK	Apr 27, 1998	Substantially Equivalent	Dade Behring, Inc.
K974325	CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN	Dec 08, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K972513	TINAQUANT MYOGLOBIN ASSAY	Jul 28, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K965213	STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY	Feb 10, 1997	Substantially Equivalent	Dade Intl., Inc.
K963680	TARGET MYOGLOBIN TEST	Feb 06, 1997	Substantially Equivalent	Texas Immunology, Inc.
K962344	MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)	Aug 15, 1996	Substantially Equivalent	Bayer Corp.
K951634	ACCESS MYOGLOBIN REAGENTS	Sep 27, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K952360	CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN	Aug 14, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K942052	LIFESIGN MI MYOGLOBIN	Feb 07, 1995	Substantially Equivalent	Princeton Biomedix
K923195	MYOGLOBIN ELISA TEST KIT	Nov 06, 1992	Substantially Equivalent	Immuno Diagnostic Center, Inc.
K922125	STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY	Jul 21, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922387	DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL	Jul 15, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K915233	MYOGLOBIN RIA TEST KIT	Mar 30, 1992	Substantially Equivalent	Pro Diagnostics, Inc.
K915850	OPUS MYOGLOBIN TEST SYSTEM	Mar 17, 1992	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K905202	TURBIQUANT MYOGLOBIN	Dec 13, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K903687	TURBIQUANT MYOGLOBIN	Oct 16, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K904038	MYOGLOBIN RIA TEST KIT	Sep 24, 1990	Substantially Equivalent	Immuno Diagnostic Center, Inc.
K902154	NA LATEX MYOGLOBIN TEST	Jun 01, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K863730	MYOLEX	Oct 15, 1986	Substantially Equivalent	Orion Corp.
K780982	KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT	Jun 22, 1978	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.
K772095	HEMAGGLUTINATION INHIBITION TEST	Jan 05, 1978	Substantially Equivalent	Miles Laboratories, Inc.
K771242	ANTISERA TO HUMAN FAB FRAGMENT	Aug 03, 1977	Substantially Equivalent	Kent Laboratories, Inc.