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., Roche Diagnostics and Phc Corporation.
FDA 510(k) Cleared Immunoassay Method, Troponin Subunit Devices (Product Code MMI)
About Product Code MMI - Regulatory Context
510(k) Submission Activity
94 total 510(k) submissions under product code MMI since 1994, with 94 receiving FDA clearance (average review time: 138 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
Recent submissions under MMI have taken an average of 196 days to reach a decision - up from 135 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 →