Cleared Traditional

K020397 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE ...

K020397 is the FDA 510(k) clearance for MICROSCAN SYNERGIES PLUS GRAM NEGATIVE ... by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K020397 · Dade Behring, Inc. · Microbiology device
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Apr 2002
Decision
75d
Days
Class 2
Risk

K020397 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-.... 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 April 22, 2002 after a review of 75 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 K020397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2002
Decision Date April 22, 2002
Days to Decision 75 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
27d faster than avg
Panel avg: 102d · This submission: 75d
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 K020397.
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)
K020410 · Dade Behring, Inc. · Jun 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020321 · Becton, Dickinson & CO · May 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
K020398 · Dade Behring, Inc. · May 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
K020319 · Dade Behring, Inc. · Apr 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · Becton, Dickinson & CO · Apr 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · bioMerieux, Inc. · Mar 2002