# K020319: Microscan Synergies Plus Gram Negative Mic/Combo Panels with Ampicillin/Sulbactam (0.5/0.25-64/34 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 17, 2002 after 77 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 Ampicillin/Sulbactam on the Synergies plus™ Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Ampicillin/Sulbactam susceptibility testing in this panel are: Escherichia coli Klebsiella spp Proteus mirabilis Proteus vulgans Providencia rettgeri Providencia stuartii The MicroScan® Synergies plus” Gram-Negative with Ampicillin/Sulbactam is not intended for use with: Acinetobacter calcoaceticus Citrobacter spp. Enterobacter spp. Morganella morganii Salmonella spp. Shigella spp.

Source page: https://510kreport.com/device/K020319
Methodology: https://510kreport.com/methodology