Cleared Special

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE (K050585) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050585 · Dade Behring, Inc. · Microbiology device
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Mar 2005
Decision
11d
Days
Class 2
Risk

K050585 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 18, 2005 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K050585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date March 18, 2005
Days to Decision 11 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 102d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Microbiology devices follow this clearance model.

Regulatory Peers - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 44
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K050585.
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K063099 · Dade Behring, Inc. · Nov 2006