# K230479: ComASP Cefiderocol 0.008-128

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: May 18, 2023 after 85 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtiter panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in μg/mL using over overnight incubation and manual reading procedures. ComASP® Cefiderocol at concentrations of 0.008-128 μg/mL should be interpreted at 16-20 hours of incubation. ComASP® Cefiderocol can be used to determine the MIC of cefiderocol against the following microorganisms for which cefiderocol has been shown to be active clinically and in vitro according to the FDA drug approved label: Acinetobacter baumannii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens

Source page: https://510kreport.com/device/K230479
Methodology: https://510kreport.com/methodology