Cleared Traditional

K062293 - MICROSCAN MICROSTREP PLUS PANEL CHLORAM...

K062293 is the FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS PANEL CHLORAM... by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K062293 · Dade Behring, Inc. · Microbiology device
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Aug 2006
Decision
17d
Days
Class 2
Risk

K062293 is an FDA 510(k) clearance for the MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML). 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 August 24, 2006 after a review of 17 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K062293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2006
Decision Date August 24, 2006
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 36
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K062293.
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585 · Dade Behring, Inc. · Sep 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596 · Dade Behring, Inc. · Sep 2006
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
K062290 · Dade Behring, Inc. · Sep 2006
MICROSCAN MICROSTREP PLUS PANEL
K061872 · Dade Behring, Inc. · Aug 2006
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)
K062179 · Dade Behring, Inc. · Aug 2006
MICROSCAN MICROSTREP PLUS PANEL
K062276 · Dade Behring, Inc. · Aug 2006