Myoglobin, Antigen, Antiserum, Control
FDA product code DDR · Class II (moderate risk) · 21 CFR 866.5680 · Immunology
46510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Beckman Coulter Inc. 4
- Diagnostic Products Corp. 3
- Behring Diagnostics, Inc. 3
- Dade Behring, Inc. 3
- Immuno Diagnostic Center, Inc. 2
- Baxter Diagnostics, Inc. 2
- Boehringer Mannheim Corp. 2
- Roche Diagnostics Corp. 2
- Princeton BioMeditech Corp. 1
- Tosoh Medics, Inc. 1
- Chiron Diagnostics Corp. 1
- Texas Immunology, Inc. 1
- Bayer Corp. 1
- Bio-Rad Laboratories, Inc. 1
- Kent Laboratories, Inc. 1
- Princeton Biomedix 1
- Pro Diagnostics, Inc. 1
- Pb Diagnostic Systems, Inc. 1
- Orion Corp. 1
- Diazyme Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231832 | Access MyoglobinDDR · Traditional | Beckman Coulter, Inc. | 09/18/2023SE |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control SetDDR · Traditional | Diazyme Laboratories | 06/07/2013SE |
| K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorDDR · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/03/2012SE |
| K083260 | Elecsys Myoglobin Stat, and Elecsys MyoglobinDDR · Traditional | Roche Diagnostics | 10/16/2009SE |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsDDR · Traditional | Beckman Coulter, Inc. | 02/20/2009SE |
| K061683 | Tina-Quant Myoglobin GEN.2 Test SystemDDR · Traditional | Roche Diagnostics Corp. | 07/21/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | Fisher Diagnostics | 01/24/2005SE |
| K042982 | Quantex MyoglobinDDR · Traditional | Instrumentation Laboratory CO | 12/22/2004SE |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/05/2003SE |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional | Beckman Coulter, Inc. | 06/28/2002SE |
| K012040 | Ramp Myoglobin AssayDDR · Traditional | Response Biomedical Corp. | 12/18/2001SE |
| K010700 | Randox MyoglobinDDR · Traditional | Randox Laboratories, Ltd. | 05/08/2001SE |
| K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316DDR · Traditional | Beckman Coulter, Inc. | 02/18/2000SE |
| K992976 | K-Assay Myoglobin Assay, K-Assay Myoglobin CalibratorDDR · Traditional | Kamiya Biomedical Co. | 11/01/1999SE |
| K991796 | Immulite Turbo Myoglobin, Models LSKMY1, LSKMY5DDR · Special | Diagnostic Products Corp. | 06/09/1999SE |
| K991277 | Modification to Immulite Myoglobin, Model LKMY1, LKMY5DDR · Special | Diagnostic Products Corp. | 04/27/1999SE |
| K984145 | Olympus Myoglobin Immunoturbidmetric ReagentDDR · Traditional | Olympus Diagnostica GmbH | 12/23/1998SE |
| K984065 | Stratus (R) CS Myoglobin (Myo) TestpakDDR · Traditional | Dade Behring, Inc. | 12/14/1998SE |
| K984191 | Myoglobin Flex Reagent CartridgeDDR · Traditional | Dade Behring, Inc. | 12/10/1998SE |
| K983970 | Immulite Myoglobin, Model LKMY1 and LKMY5DDR · Traditional | Diagnostic Products Corp. | 11/25/1998SE |
| K983848 | Abbott Axsym MyoglobinDDR · Traditional | Abbott Laboratories | 11/16/1998SE |
| K982679 | Multiquant (R) Quantitative Myoglobin TestDDR · Traditional | Spectral Diagnostics, Inc. | 10/07/1998SE |
| K983176 | Elecsys Myoglobin Stat AssayDDR · Traditional | Boehringer Mannheim Corp. | 09/24/1998SE |
| K981012 | Aia-Pack Myoglobin AssayDDR · Traditional | Tosoh Medics, Inc. | 05/28/1998SE |
| K981102 | Stratus CS Myoglobin (Myo) TestpakDDR · Traditional | Dade Behring, Inc. | 04/27/1998SE |
| K974325 | Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional | Chiron Diagnostics Corp. | 12/08/1997SE |
| K972513 | Tinaquant Myoglobin AssayDDR · Traditional | Boehringer Mannheim Corp. | 07/28/1997SE |
| K965213 | Stratus Myoglobin Gluorometric Enzyme ImmunoassayDDR · Traditional | Dade Intl., Inc. | 02/10/1997SE |
| K963680 | Target Myoglobin TestDDR · Traditional | Texas Immunology, Inc. | 02/06/1997SE |
| K962344 | Myoglobin Assay for the Technicon Immuno 1 System (In-Vitro Diagnostic System)DDR · Traditional | Bayer Corp. | 08/15/1996SE |
| K951634 | Access Myoglobin ReagentsDDR · Traditional | Bio-Rad Laboratories, Inc. | 09/27/1995SE |
| K952360 | Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/MyoglobinDDR · Traditional | Princeton BioMeditech Corp. | 08/14/1995SE |
| K942052 | Lifesign Mi MyoglobinDDR · Traditional | Princeton Biomedix | 02/07/1995SE |
| K923195 | Myoglobin Elisa Test KitDDR · Traditional | Immuno Diagnostic Center, Inc. | 11/06/1992SE |
| K922125 | Stratus Myoglobin Fluorometric Enzyme ImmunoassayDDR · Traditional | Baxter Diagnostics, Inc. | 07/21/1992SE |
| K922387 | Dade(R) Myoglobin Controls Tri-LevelDDR · Traditional | Baxter Diagnostics, Inc. | 07/15/1992SE |
| K915233 | Myoglobin Ria Test KitDDR · Traditional | Pro Diagnostics, Inc. | 03/30/1992SE |
| K915850 | Opus Myoglobin Test SystemDDR · Traditional | Pb Diagnostic Systems, Inc. | 03/17/1992SE |
| K905202 | Turbiquant MyoglobinDDR · Traditional | Behring Diagnostics, Inc. | 12/13/1990SE |
| K903687 | Turbiquant MyoglobinDDR · Traditional | Behring Diagnostics, Inc. | 10/16/1990SE |
| K904038 | Myoglobin Ria Test KitDDR · Traditional | Immuno Diagnostic Center, Inc. | 09/24/1990SE |
| K902154 | Na Latex Myoglobin TestDDR · Traditional | Behring Diagnostics, Inc. | 06/01/1990SE |
| K863730 | MyolexDDR · Traditional | Orion Corp. | 10/15/1986SE |
| K780982 | Kits, Ria, Myoglobin, Human, MeasurementDDR · Traditional | Cis Radiopharmaceuticals, Inc. | 06/22/1978SE |
| K772095 | Hemagglutination Inhibition TestDDR · Traditional | Miles Laboratories, Inc. | 01/05/1978SE |
| K771242 | Antisera to Human Fab FragmentDDR · Traditional | Kent Laboratories, Inc. | 08/03/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1476-2024 Class II | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of… | Abbott Laboratories | 02/21/2024Open, Classified |
| Z-2445-2019 Class II | The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the…The firm conducted internal investigations that confirmed customer complaints of quality control (QC)… | Roche Diagnostics Operations, Inc. | 07/02/2019Terminated |
| Z-2072-2018 Class II | ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2899-2016 Class II | Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the…Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the… | Siemens Healthcare Diagnostics, Inc | 08/08/2016Terminated |
| Z-0618-2016 Class II | Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnosticStratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-0612-2016 Class II | Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-1050-2009 | AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | Abbott Laboratories | 01/19/2009Terminated |
| Z-1396-2009 | Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a…Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A -… | Beckman Coulter Inc | 09/27/2007Terminated |
| Z-1030-2007 | AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |