# K020142: Microscan Synergies Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 14, 2002 after 57 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 antimicrobials Ofloxacin, Norfloxacin, Levofloxacin, Lomefloxacin, Sparfloxacin, and Ciprofloxacin on the Synergies plusm__Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Ofloxacin (Ofl), Norfloxacin (Nxn), Levofloxacin (Lvx), Lomefloxacin (Lmf), Sparfloxacin (Sfx), and Ciprofloxacin (Cp) susceptibility testing in this panel are listed in the attached table.

Source page: https://510kreport.com/device/K020142
Methodology: https://510kreport.com/methodology