# K071268: Microscan Synergies Plus Gram Positive Mic/Combo Panels with Tetracycline

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 26, 2007 after 50 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 plus1 m 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 +/- 1°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 tetracycline, at concentrations of 0.25 to 16 tg/nml (7-Dilution MIC Sequence), 0.5 - 8 ptg/ml (5-Dilution BP Sequence), and 2 - 8 ltg/ml (3-Dilution BP Dilution Sequence), for all Staphylococcus species and Enterococcus species to the test panel. The Gram-positive organisms which may be used for tetracycline susceptibility testing in this panel are: * Staphylococcus aureus * Streptococcusfaecalis(Enterococcusfriecalis)

Source page: https://510kreport.com/device/K071268
Methodology: https://510kreport.com/methodology