Cleared Traditional

K061872 - MICROSCAN MICROSTREP PLUS PANEL

K061872 is the FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS PANEL by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K061872 · Dade Behring, Inc. · Microbiology device
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Aug 2006
Decision
51d
Days
Class 2
Risk

K061872 is an FDA 510(k) clearance for the MICROSCAN MICROSTREP PLUS PANEL. 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 23, 2006 after a review of 51 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 K061872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date August 23, 2006
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
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 K061872.
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 CHLORAMPHENICOL (1 TO 32 MCG/ML)
K062293 · 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
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243 · Trek Diagnostic Systems, Inc. · Jan 2006