Cleared Traditional

K063102 - MICROSCAN MICROSTREP PLUS PANEL CEFACLO...

K063102 is the FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS PANEL CEFACLO... by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K063102 · Dade Behring, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
30d
Days
Class 2
Risk

K063102 is an FDA 510(k) clearance for the MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 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 November 9, 2006 after a review of 30 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 K063102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date November 09, 2006
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
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 K063102.
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
K081013 · Siemens Healthcare Diagnostics · Sep 2008
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
K071316 · Dade Behring, Inc. · Aug 2007
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
K063299 · Dade Behring, Inc. · Nov 2006
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
K063099 · Dade Behring, Inc. · Nov 2006
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
K063101 · Dade Behring, Inc. · Nov 2006
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
K063065 · Dade Behring, Inc. · Oct 2006