Cleared Traditional

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260) - FDA 510(k) Clearance

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

K083260 · Roche Diagnostics · Chemistry device
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Oct 2009
Decision
345d
Days
Class 2
Risk

K083260 is an FDA 510(k) clearance for the ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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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Submission Details

510(k) Number K083260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2008
Decision Date October 16, 2009
Days to Decision 345 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
257d slower than avg
Panel avg: 88d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K083260.
Access Myoglobin
K231832 · Beckman Coulter, Inc. · Sep 2023
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp. · Apr 1999
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · Dade Behring, Inc. · Dec 1998