# K020246: Microscan Synergies Plus Gram Negative Mic/Combo Panels with Imipenem (0.25, 1-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 6, 2002 after 13 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 12 (11 Class I)
- 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.
1 of 1 device in its family (counting itself) has 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 MIC/Combo Panels: named in the summary without a submission number

## Recalls of this device
- Aug 21, 2013 · Class I · Z-2124-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2128-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2126-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2129-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2122-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2123-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2120-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2121-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2127-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2119-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Aug 21, 2013 · Class I · Z-2125-2013: Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
- Jul 31, 2008 · Not classified · Z-0540-2009: Falsely lowered imipenem MICs may result, leading to major errors in results.

## Indications for use
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 (Enterobacteriaceae, glucose non-fermenters, and non- Enterobacteriaceae glucose fermenters. After inoculation panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert. This particular submission is for the antimicrobial Imipenem on the Synergies plus™ Gram-Negative MIC/Combo Panels. The Gram-Negative organisms which may be used for Imipenem susceptibility testing in this panel are: Achromobacter spp Acinetobacter spp Aeromonas hydrophila Alcaligenes spp Citrobacter spp Escherichia coli Enterobacter spp Hafnia alvei Klebsiella spp Morganella morganii Pasteurella multocida Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia spp Shigellia spp Salmonella spp Yersinia spp

Source page: https://510kreport.com/device/K020246
Methodology: https://510kreport.com/methodology