Cleared Special

K033482 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

K033482 is an FDA 510(k) clearance for MICROSCAN SYNERGIES PLUS GRAM NEGATIVE ..., manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Special 510(k) pathway after a 22-day FDA review.

K033482 · Dade Behring, Inc. · Microbiology device
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Nov 2003
Decision
22d
Days
Class 2
Risk

K033482 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25.... 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 November 26, 2003 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033482

510(k) Number K033482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date November 26, 2003
Days to Decision 22 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

LON Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K033482.
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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
K033558 · Becton, Dickinson & CO · Dec 2003
MYCOPLASMA IGG
K033064 · Trinity Biotech USA · Nov 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · bioMerieux, Inc. · Nov 2003
VITEK 2 GRAM NEGATIVE GATIFLOXACIN
K032788 · bioMerieux, Inc. · Nov 2003
VITEK GRAM NEGATIVE GATIFLOXACIN
K032711 · bioMerieux, Inc. · Oct 2003
K033482 · MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
Download PDF Dade Behring, Inc.