# K062705: Synergies Plus Gram-Positive Mic/Combo Panels with Linezolid

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 20, 2006 after 39 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5- 18 hours at 350 C +/- IPC, in a WalkAway* SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 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 linezolid, at concentrations of 0.5 to 16 fg/ml Long Dilution Sequence and 0.5 -4 pg/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel. The Gram-positive organisms which may be used for linezolid susceptibility testing in this panel are: Enterococcusfaecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)

Source page: https://510kreport.com/device/K062705
Methodology: https://510kreport.com/methodology