# K033948: Microscan Dried Gram-Negative Mic/Combo Panels (Gemifloxacin)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 1, 2004 after 73 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 Dried Gram-Negative and Gram-Positive MIC/Combo: named in the summary without a submission number

## Indications for use
The MicroScan® Dried 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 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial gemifloxacin at concentrations of 0.002 to 16 mcg/ml to the test panel. The gram-negative organisms which may be used for gemifloxacin susceptibility testing in this panel are: Klebsiella pneumoniae Klebsiella oxytoca Proteus vulgaris

Source page: https://510kreport.com/device/K033948
Methodology: https://510kreport.com/methodology