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 16, 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950
bioMerieux, Inc.
Chemistry · 82d
Cleared Mar 31, 2003
VBL SERUM TROPONIN I TEST, MODEL 1001
K023505
Vancouver Biotech , Ltd.
Chemistry · 164d
Cleared Mar 19, 2003
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
K030057
Spectral Diagnostics, Inc.
Chemistry · 71d
Cleared Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
K024193
Ortho-Clinical Diagnostics
Chemistry · 63d
Cleared Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946
Princeton BioMeditech Corp.
Chemistry · 34d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814
Beckman Coulter, Inc.
Chemistry · 116d
Cleared May 24, 2002
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950
Spectral Diagnostics, Inc.
Chemistry · 60d
Cleared Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
K020662
Ortho-Clinical Diagnostics
Chemistry · 42d
Cleared Feb 01, 2002
SPECTRAL'S TROPONIN I
K014105
Spectral Diagnostics, Inc.
Chemistry · 50d
Cleared Jan 08, 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062
Biocheck, Inc.
Chemistry · 118d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024
First Medical, Inc.
Chemistry · 12d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820
Tosoh Medics, Inc.
Chemistry · 113d
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 Mar 13, 2001
ALPHA DX SYSTEM
K010562
First Medical, Inc.
Chemistry · 15d
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