# K032706: Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 10, 2004 after 161 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K101425: Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series (2010), 0 descendants of its own

## 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 Ertapenem at concentrations of 0.002 to 32 mcg/mI to the test panel. The gram-negative organisms which may be used for Ertapenem susceptibility testing in this panel are: Citrobacterfreundii Citrobacterkoseri Enterobacteraerogenes Enterobactercloacae Escherichiacoli Klebsiella oxytoca (excluding ESBL producing strains) Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Serratiamarcescens

Source page: https://510kreport.com/device/K032706
Methodology: https://510kreport.com/methodology