MMI · Class II · 21 CFR 862.1215

FDA Product Code MMI: Immunoassay Method, Troponin Subunit

Troponin measurement is the gold standard for diagnosing myocardial injury. FDA product code MMI covers immunoassay systems for the detection and quantification of cardiac troponin subunits.

These high-sensitivity assays measure troponin I or troponin T — proteins released into the bloodstream when cardiac muscle cells are damaged — enabling the rapid diagnosis of acute myocardial infarction and risk stratification of chest pain patients in emergency settings.

MMI devices are Class II medical devices, regulated under 21 CFR 862.1215 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Beckman Coulter, Inc., Dade Behring, Inc. and Boehringer Mannheim Corp..

95
Total
95
Cleared
140d
Avg days
1994
Since
95 devices
49–72 of 95
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429
Beckman Coulter, Inc.
Chemistry · 112d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313
Dade Behring, Inc.
Chemistry · 77d
Cleared Mar 29, 2001
BAYER ADVIA IMS SYSTEM
K010201
Bayer Corp.
Chemistry · 66d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Dec 06, 1999
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309
Bayer Corp.
Chemistry · 63d
Cleared Dec 06, 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353
Bayer Corp.
Chemistry · 62d
Cleared Oct 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366
Ortho-Clinical Diagnostics, Inc.
Chemistry · 85d
Cleared Oct 04, 1999
CARDIOQUANT TROPONIN I TEST
K992127
Spectral Diagnostics, Inc.
Chemistry · 103d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177
Dade Behring, Inc.
Chemistry · 85d
Cleared Jun 09, 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795
Diagnostic Products Corp.
Chemistry · 14d
Cleared Dec 23, 1998
AIA-PACK TROPONIN I ASSAY
K984359
Tosoh Medics, Inc.
Chemistry · 16d
Cleared Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093
Dade Behring, Inc.
Chemistry · 28d
Cleared Dec 08, 1998
ELECSYS TROPONIN T STAT TEST
K984105
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Dec 07, 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972
Diagnostic Products Corp.
Chemistry · 28d
Cleared Jul 06, 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882
Princeton BioMeditech Corp.
Chemistry · 39d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098
Dade Behring, Inc.
Chemistry · 32d
Cleared Mar 03, 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Feb 04, 1998
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
K974839
First Medical, Inc.
Chemistry · 42d
Cleared Jan 16, 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818
Radiometer America, Inc.
Chemistry · 24d
Cleared Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616
Bayer Corp.
Chemistry · 73d
Cleared Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
K974103
Abbott Laboratories
Chemistry · 25d
Cleared Nov 10, 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075
Beckman Instruments, Inc.
Chemistry · 12d
Cleared Oct 20, 1997
TROPONIN (TROP) METHOD
K973650
Dade Chemistry Systems, Inc.
Chemistry · 25d
Cleared Jul 23, 1997
TARGET CARDIAC TROPONIN I TEST
K972094
Texas Immunology, Inc.
Chemistry · 49d