# K162740: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 21, 2017 after 172 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: 1 generation back to K083262 (2009). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083262: Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML), Siemens Healthcare Diagnostics (2009) Summary page 4.

## Most influential descendants
- K172337: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (2017), 0 descendants of its own
- K172912: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (2017), 0 descendants of its own
- K172255: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (2017), 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 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 reformulated antimicrobial imipenem at concentrations of 0.25 to 8 μg/ml to the test panel. The gram-negative organisms which may be used for imipenem susceptibility testing in this panel are: Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia coli, Klebsiella spp. Morganella morganii, Proteus vulgaris, Providencia rettgeri, and Pseudomonas aeruginosa

Source page: https://510kreport.com/device/K162740
Methodology: https://510kreport.com/methodology