# K172337: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 15, 2017 after 135 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
Longest line of descent: 2 generations back to K083262 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162740: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL), Beckman Coulter, Inc. (2017) Summary page 4.

## 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 ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 μg/mL to the test panel. The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are: Citrobacter freundii complex, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Providencia rettgeri, Providencia stuartii, and Serratia marcescens

Source page: https://510kreport.com/device/K172337
Methodology: https://510kreport.com/methodology