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
Stable submission activity - 5 submissions in the last 2 years
Review times increasing: avg
230d
recently vs 134d historically
FDA 510(k) Cleared Immunoassay Method, Troponin Subunit Devices (Product Code MMI)
95 devices
Cleared
Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
Chemistry
90d
Cleared
Aug 01, 2025
Access hsTnI
Beckman Coulter, Inc.
Chemistry
266d
Cleared
Jun 16, 2025
Access hsTnI
Beckman Coulter, Inc.
Chemistry
266d
Cleared
Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
268d
Cleared
Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
Siemens Healthcare Diagnostics, Inc.
Chemistry
90d
Cleared
Mar 20, 2024
PATHFAST®hs-cTnI-II
Phc Corporation
Chemistry
261d
Cleared
Dec 18, 2023
Access hsTnI
Beckman Coulter, Inc.
Chemistry
452d
Cleared
Dec 04, 2023
Access hsTnI
Beckman Coulter, Inc.
Chemistry
270d
Cleared
May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
Chemistry
27d
Cleared
May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
Chemistry
625d
Cleared
Sep 21, 2021
Elecsys Troponin T Gen 5
Roche Diagnostics
Chemistry
477d
Cleared
Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Division
Chemistry
88d
Cleared
May 17, 2019
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
63d
Cleared
Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
200d
Cleared
Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics, Inc.
Chemistry
415d
Cleared
Jul 12, 2018
ADVIA Centaur High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics, Inc.
Chemistry
437d
Cleared
Jun 14, 2018
Access hsTnl
Beckman Coulter, Inc.
Chemistry
272d
Cleared
Jun 12, 2018
Access hs Tnl
Beckman Coulter, Inc.
Chemistry
270d
Cleared
Jan 18, 2017
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
Roche Diagnostics
Chemistry
93d
Cleared
Sep 25, 2013
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Beckman Coulter, Inc.
Chemistry
464d
Cleared
Jun 14, 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Beckman Coulter, Inc.
Chemistry
417d
Cleared
Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
Roche Diagnostics
Chemistry
338d
Cleared
Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
Siemens Healthcare Diagnostics
Chemistry
21d
Cleared
Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
bioMerieux, Inc.
Chemistry
414d
About Product Code MMI - Regulatory Context
510(k) Submission Activity
95 total 510(k) submissions under product code MMI since 1994, with 95 receiving FDA clearance (average review time: 140 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA 510(k) Review Time - MMI Product Code
Recent submissions under MMI have taken an average of 230 days to reach a decision - up from 134 days historically. Manufacturers should account for longer review timelines in current project planning.
MMI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →