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Elecsys Troponin T STAT Test

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K984105

Overview

The Elecsys Troponin T STAT Test is an immunoassay method for the quantitative measurement of cardiac troponin T in human serum or plasma. Cardiac troponin T is a biomarker used to detect myocardial injury, aiding in the diagnosis of acute coronary syndromes, including myocardial infarction. This device employs an electrochemiluminescence immunoassay (ECLIA) to provide rapid and sensitive detection of troponin T levels, supporting clinical decision-making in emergency and cardiac care settings.

This test is designed for use on cobas e immunoassay analyzers and is supplied as a single-use reagent for in vitro diagnostic use. It is intended for laboratory settings and requires proper handling, storage at 2–8°C, and adherence to manufacturer instructions for preparation and operation. The device carries FDA 510(k) clearance (K984105) under the Clinical Chemistry advisory committee, classified as a Class II medical device under regulation number 862.1215. No third-party reprocessing is permitted.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984105 Date8 Dec 1998ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-0512-06 FDA Unclassified (pre-2012) initiated 31 Jan 2006

    A false negative result may be reported.

    • Terminated Z-0870-03 FDA Unclassified (pre-2012) initiated 25 Apr 2003

    Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

Specification

510(k)

510(k) Number
FDA Product Code
MMI
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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