Cleared Traditional

TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

K052503 · Bayer Healthcare, LLC · Chemistry
Dec 2005
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K052503 is an FDA 510(k) clearance for the TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on December 14, 2005, 92 days after receiving the submission on September 13, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K052503 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2005
Decision Date December 14, 2005
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — MMI Immunoassay Method, Troponin Subunit

All 93
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
K252393 · Ortho-Clinical Diagnostics, Inc. · Oct 2025
Access hsTnI
K243483 · Beckman Coulter, Inc. · Aug 2025
Access hsTnI
K242870 · Beckman Coulter, Inc. · Jun 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · Abbott Point of Care, Inc. · Jan 2025
Atellica? IM High-Sensitivity Troponin I (TnIH)
K241165 · Siemens Healthcare Diagnostics, Inc. · Jul 2024
PATHFAST?hs-cTnI-II
K231974 · Phc Corporation · Mar 2024