Cleared Traditional

K062705 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO ...

K062705 is the FDA 510(k) clearance for SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO ... by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K062705 · Dade Behring, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
39d
Days
Class 2
Risk

K062705 is an FDA 510(k) clearance for the SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on October 20, 2006 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 K062705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2006
Decision Date October 20, 2006
Days to Decision 39 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
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 279
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K062705.
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML
K062938 · Dade Behring, Inc. · Nov 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
K062944 · Becton, Dickinson & CO · Nov 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML
K062687 · Becton, Dickinson & CO · Oct 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
K062680 · Becton, Dickinson & CO · Oct 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML
K062207 · Becton, Dickinson & CO · Sep 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
K062206 · Becton, Dickinson & CO · Sep 2006