Cleared Traditional

ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082699 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
338d
Days
Class 2
Risk

K082699 is an FDA 510(k) clearance for the ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 19, 2009 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

Submission Details

510(k) Number K082699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date August 19, 2009
Days to Decision 338 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 88d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - MMI Immunoassay Method, Troponin Subunit

All 93
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K082699.
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