# K041150: Microscan Synergies Plus Gram-Negative Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 22, 2004 after 80 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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

## Indications for use
The 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. 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-CO2 incubator and the AST pdrtions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefazolin, at concentrations of 0.5 to 32 gg/nI, to the test panel. The gram-negative organisms which may be used for Cefazolin susceptibility testing in this panel are: Escherichia coli Klebsiella spp. Proteus mirabilis The MicroScan® Synergies plus7' Gram-Negative Panels with Cefazolin is not intended for use with: Klebsiella oxytoca Proteuspenneri Enterobacterspp. Providenciaspp Citrobacterfreundii Serratiaspp Morganella morganii Yersinia enterolitica Proteus vulgaris

Source page: https://510kreport.com/device/K041150
Methodology: https://510kreport.com/methodology