# K071076: Synergies Plus Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 21, 2007 after 35 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 35°C +/- I°C, 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 oxacillin, at concentrations of 0.03 to 8 pg/ml Long Dilution Sequence for S. aureus and S. lugdunensis, and 0.03 - 2 lpg/ml 7-Dilution MIC Dilution Sequence, and 0.12 - 2 jig/ml 5-Dilution Breakpoint Sequence, for all Staphylococcus species, to the test panel. The Gram-positive organisms which may be used for oxacillin susceptibility testing in this panel are: * Staphylococcus species

Source page: https://510kreport.com/device/K071076
Methodology: https://510kreport.com/methodology