# K020185: Microscan Rapid/S Plus Gram-Negative Mic Combo Panels with Gentamicin (0.12-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 6, 2002 after 19 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
This particular submission is for the antimicrobial Gentamicin on the Synergies plus" Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Gentamicin susceptibility testing in this panel are: Citrobacter amalonaticus Citrobacter koseri (diversus) Citrobacter freundii Citrobacter spp Escherichia coli Enterobacter aerogenes Enterobacter agglomerans Enterobacter cloacae Enterobacter sakazakii Enterobacter spp Klebsiella oxytoca Klebsiella ozaenae Klebsiella pneumoniae Klebsiella rhinoscleromatis Klebsiella spp Proteus mirabilis Proteus vulgaris Proteus spp Pseudomonas aeruginosa Serratia spp Serratia marcescens Shigella flexneri Shigella sonnei Shigella spp Salmonella spp

Source page: https://510kreport.com/device/K020185
Methodology: https://510kreport.com/methodology