# K243804: MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 20, 2025 after 252 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: 4 generations back to K190109 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202343: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ), Beckman Coulter, Inc. (2020) Summary page 5.

## Indications for use
The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and 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 cefepime at concentrations of 0.12-64 µg/mL to the test panel. Testing is indicated for Enterobacterales, Pseudomonas aeruginosa and Aeromonas spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage. The MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64µg/mL) has demonstrated acceptable performance with the following organisms: Enterobacterales (Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter koseri, (formerly Citrobacter diversus), Citrobacter freundii complex (Citrobacter freudnii, Citrobacter werkmanii and Citrobacter youngae), Klebsiella oxytoca, Morganella morganii, Proteus vulgaris, Providencia stuartii, Providencia rettgeri, Serratia marcescens) Pseudomonas aeruginosa Aeromonas spp.

Source page: https://510kreport.com/device/K243804
Methodology: https://510kreport.com/methodology