# K051478: Microscan Synergies Plus Gram Positive Mic/Combo Panels - Rifampin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 27, 2005 after 54 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® Synergies plus' Gram-Negative MIC/Combo Panels: named in the summary without a submission number
- (no number) MicroScan® Dried Gram-Positive Panels: named in the summary without a submission number

## Indications for use
The MicroScan® Synergies plus' Gram-Positive 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-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- IC, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO 2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Rifampin, at concentrations of 0.25 to 8 pIg/ml, to the test panel. The gram-positive organisms which may be used for Rifampin susceptibility testing in this panel are: Staphylococcus aureus (including methicillin-resistant strains/MRSA) Staphylococcus epidermidis

Source page: https://510kreport.com/device/K051478
Methodology: https://510kreport.com/methodology