# K033940: Microscan Dried Gram-Negative Mic/Combo Panels-Amoxicillin/Clavulanate Potassium (Augmentin)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 25, 2004 after 68 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- 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 Panels: 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 350C +/- 10C 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 amoxicillin/K. clavulanate at concentrations of 0.25/0.12 to 128/64 mcg/ml to the test panel. The gram-negative organisms which may be used for amoxicillin/K. clavulanate susceptibility testing in this panel are: Enterobacter species Escherichia coli Klebsiella species Proteus mirabills

Source page: https://510kreport.com/device/K033940
Methodology: https://510kreport.com/methodology