Who is the manufacturer of TROPONIN-I TEST SYSTEM?

Dade Intl., Inc. filed the 510(k) submission for TROPONIN-I TEST SYSTEM (K964862).

What is the FDA product code for TROPONIN-I TEST SYSTEM?

MMI. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for TROPONIN-I TEST SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TROPONIN-I TEST SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TROPONIN-I TEST SYSTEM

K964862 · Dade Intl., Inc. · MMI · Feb 10, 1997 · Clinical Chemistry

Device Facts

Record ID	K964862
Device Name	TROPONIN-I TEST SYSTEM
Applicant	Dade Intl., Inc.
Product Code	MMI · Clinical Chemistry
Decision Date	Feb 10, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for use in patients with suspected myocardial infarction or acute coronary syndromes to aid in diagnosis and risk stratification for mortality.

Regulatory Classification

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)

Related Devices

K972094 — TARGET CARDIAC TROPONIN I TEST · Texas Immunology, Inc. · Jul 23, 1997
K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) · Chiron Diagnostics Corp. · Mar 3, 1998
K981098 — STRATUS CS CARDIAC TROPONIN I TESTPAK · Dade Behring, Inc. · Apr 27, 1998
K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT · Biocheck, Inc. · Jan 8, 2002
K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM · Bayer Healthcare, LLC · Dec 30, 2005

Submission Summary (Full Text)

{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