← Product Code [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI) · K964862 # TROPONIN-I TEST SYSTEM (K964862) _Dade Intl., Inc. · MMI · Feb 10, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K964862 ## Device Facts - **Applicant:** Dade Intl., Inc. - **Product Code:** [MMI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1215 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators is an in vitro diagnostic test for the quantitative measurement of cardiac troponin-I in human serum. The device is intended for use as an aid in the diagnosis of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. ## Device Story Fluorometric enzyme immunoassay for quantitative measurement of cardiac troponin-I in human serum; used in clinical laboratory settings by trained personnel. Device measures troponin-I levels to assist clinicians in diagnosing myocardial infarction and assessing mortality risk in acute coronary syndrome patients. Output provides numerical concentration values used to inform clinical decision-making regarding patient management and prognosis. ## Technological Characteristics Fluorometric enzyme immunoassay; quantitative measurement of cardiac troponin-I in human serum. No changes to technological characteristics from predicate. ## Regulatory Identification A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. ## Predicate Devices - Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators ([K951890](/device/K951890.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964862 FEB 10 1997 # 510(k) Summary of Safety and Effectiveness Information Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators December 3, 1996 Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 Contact Person: Radha Goolabsingh at 305-392-5621 or by facsimile at 305-392-5622. Trade or Proprietary Name: Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators Common or Usual Name: Troponin-I Test System Classification Name: None Registration Number: Manufacturer Dade International Inc. 2173 N.W. 99th Avenue Miami, FL 33172 1025506 (formerly at 9750 N.W. 25 Street, Miami, FL 33172) Dade International Inc. 1851 Delaware Parkway Miami, Florida 33125 1017272 The proposed Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators is substantially equivalent in intended use and technological characteristics to the Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K951890. The proposed device is limited to modifications in the indications for use. The additional indication for use is to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. 015 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K964862](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MMI/K964862) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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