# K050585: Microscan Dried Gram Negative Mic/Combo Panels Amoxicillin/K. Clavulanate

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Mar 18, 2005 after 11 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 +/- I°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms. 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 mirabilis

Source page: https://510kreport.com/device/K050585
Methodology: https://510kreport.com/methodology