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
73–95 of 95
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
Cleared Feb 10, 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372
Boehringer Mannheim Corp.
Chemistry · 101d
Cleared Feb 10, 1997
TROPONIN-I TEST SYSTEM
K964862
Dade Intl., Inc.
Chemistry · 68d
Cleared Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
K963934
Bio-Rad Laboratories, Inc.
Chemistry · 76d
Cleared Nov 07, 1996
CARDIAC STATUS TROPONIN I
K963513
Princeton BioMeditech Corp.
Chemistry · 65d
Cleared Jun 11, 1996
ELECSYS TROPONIN T
K961500
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Feb 14, 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Jan 25, 1996
OPUS TROPONIN I
K955284
Behring Diagnostics, Inc.
Chemistry · 70d
Cleared Nov 09, 1995
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
K952478
Boehringer Mannheim Corp.
Chemistry · 163d
Cleared Jul 13, 1995
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
K951890
Dade Intl., Inc.
Chemistry · 80d
Cleared Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
K924392
Boehringer Mannheim Corp.
Chemistry · 603d