# K031602: Microscan Synergies Plus Gram Negative Mic/Combo Panels with Nitrofurantoin (1-256 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 31, 2003 after 71 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 rapid/S plus Gram Negative MIC/Combo Panels: named in the summary without a submission number

## Indications for use
The 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. After inoculation, panels are incubated for 4.5 — 18 hours at 35°C +/- 1°C, in a WalkAway S/ or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Nitrofurantoin, at concentrations of 1 to 256 pg/ml, to the test panel. The gram-negative organisms which may be used for Nitrofurantoin susceptibility testing in this panel are: Escherichia coli Citrobacter amalonaticus Citrobacter freundii Citrobacter koseri (diversus) Klebsiella oxytoca Klebsiella ozaenae Klebsiella spp. * Enterobacter spp.* * Some strains of Klebsiella species and Enterobacter species are resistant to Nitrofurantoin.

Source page: https://510kreport.com/device/K031602
Methodology: https://510kreport.com/methodology