# K020168: Microscan Synergis Plus Gram Negative Mic/Combo Panels with Tobramycin (0.12-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 6, 2002 after 20 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MicroScan Dried Gram Negative MIC/Combo Panels: named in the summary without a submission number

## Indications for use
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert. This particular submission is for the antimicrobial Tobramycin on the Synergies plus™ Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Tobramycin susceptibility testing in this panel are: Citrobacter amalonaticus Klebsiella pneumoniae Citrobacter koseri (diversus) Klebsiella rhinoscleromatis Citrobacter freundii Klebsiella spp Citrobacter spp Morganella morganii Escherichia coli Proteus mirabilis Enterobacter aerogenes Proteus vulgaris Enterobacter agglomerans Proteus spp Enterobacter cloacae Providencia alcalifaciens Enterobacter sakazakii Providencia rettgeri Enterobacter spp Providencia stuartii Klebsiella oxytoca Pseudomonas aeruginosa Klebsiella ozaenae Serratia spp Serratia marcescens

Source page: https://510kreport.com/device/K020168
Methodology: https://510kreport.com/methodology