Cleared Traditional

K082699 - ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

K082699 is an FDA 510(k) clearance for ELECSYS TROPONIN I AND TROPONIN I STAT ..., manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K082699 · Roche Diagnostics · Chemistry device
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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.

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FDA 510(k) Submission Details - K082699

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
Combination Product No
PCCP Authorized No
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.

MMI Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K082699.
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
K162895 · Roche Diagnostics · Jan 2017
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
K121790 · Beckman Coulter, Inc. · Sep 2013
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
K121214 · Beckman Coulter, Inc. · Jun 2013
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
K081643 · Siemens Healthcare Diagnostics · Jul 2008
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · bioMerieux, Inc. · Dec 2007
ARCHITECT STAT TROPONIN-1
K070640 · Fisher Diagnostics · Sep 2007