DDR · Myoglobin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5680 · Class 2
Overview
| Product Code | DDR |
|---|---|
| Device Name | Myoglobin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5680 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231832 | Access Myoglobin | Beckman Coulter, Inc. | Sep 18, 2023 | SESE |
| K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | Jun 7, 2013 | SESE |
| K122599 | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Oct 3, 2012 | SESE |
| K083260 | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | Roche Diagnostics | Oct 16, 2009 | SESE |
| K080481 | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | Beckman Coulter, Inc. | Feb 20, 2009 | SESE |
| K061683 | TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM | Roche Diagnostics Corp. | Jul 21, 2006 | SESE |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | Fisher Diagnostics | Jan 24, 2005 | SESE |
| K042982 | QUANTEX MYOGLOBIN | Instrumentation Laboratory CO | Dec 22, 2004 | SESE |
| K033300 | VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | Nov 5, 2003 | SESE |
| K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 | Beckman Coulter, Inc. | Jun 28, 2002 | SESE |
| K012040 | RAMP MYOGLOBIN ASSAY | Response Biomedical Corp. | Dec 18, 2001 | SESE |
| K010700 | RANDOX MYOGLOBIN | Randox Laboratories, Ltd. | May 8, 2001 | SESE |
| K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | Beckman Coulter, Inc. | Feb 18, 2000 | SESE |
| K992976 | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR | Kamiya Biomedical Co. | Nov 1, 1999 | SESE |
| K991796 | IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 | Diagnostic Products Corp. | Jun 9, 1999 | SESE |
| K991277 | MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 | Diagnostic Products Corp. | Apr 27, 1999 | SESE |
| K984145 | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | Olympus Diagnostica GmbH | Dec 23, 1998 | SESE |
| K984065 | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | Dade Behring, Inc. | Dec 14, 1998 | SESE |
| K984191 | MYOGLOBIN FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Dec 10, 1998 | SESE |
| K983970 | IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 | Diagnostic Products Corp. | Nov 25, 1998 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 4 clearances
- Diagnostic Products Corp. — 3 clearances
- Dade Behring, Inc. — 3 clearances
- Behring Diagnostics, Inc. — 3 clearances
- Immuno Diagnostic Center, Inc. — 2 clearances
