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 Siemens Healthcare Diagnostics, Inc..
List of Immunoassay Method, Troponin Subunit devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Immunoassay Method, Troponin Subunit devices (product code MMI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →