ComASP Cefiderocol 0.008-128
510(k) K230479
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230479 | Date18 May 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JWY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ComASP Cefiderocol 0.008–128 is a Manual Antimicrobial Susceptibility Test System designed for in vitro antimicrobial susceptibility testing (AST). It quantifies the minimum inhibitory concentration (MIC) of cefiderocol against Gram-negative non-fastidious organisms, including Enterobacterales, Pseudomonas aeruginosa, Acinetobacter spp., and Stenotrophomonas maltophilia. The system employs a broth microdilution method with dried antibiotic dilutions ranging from 0.008 to 128 µg/mL to assess bacterial susceptibility.
This single-use, non-sterile test panel is supplied as a 2-test panel for qualitative determination of cefiderocol efficacy. It is intended for use in microbiology laboratories and adheres to regulatory standards under FDA 510(k) clearance (K230479). Storage and handling follow standard in vitro diagnostic procedures, with no MRI compatibility requirements. The product is classified under device class II and regulated under 21 CFR 866.1640 for antimicrobial susceptibility testing systems.
Other devices from Liofilchem S.r.l.
Questions
AI-generated answers, 1 Oct 2026
What is the ComASP Cefiderocol 0.008–128 used for?
This system performs in vitro antimicrobial susceptibility testing (AST) to determine the minimum inhibitory concentration (MIC) of cefiderocol against Gram-negative non-fastidious organisms. These include *Enterobacterales*, *Pseudomonas aeruginosa*, *Acinetobacter* spp., and *Stenotrophomonas maltophilia*. The results help guide treatment decisions by quantifying bacterial susceptibility to cefiderocol using a broth microdilution method with dried antibiotic dilutions ranging from 0.008 to 128 µg/mL.
How is the ComASP Cefiderocol 0.008–128 supplied and what is its sterility status?
The system is supplied as a single-use, non-sterile 2-test panel. Each panel contains dried antibiotic dilutions for qualitative determination of cefiderocol efficacy. Since it is non-sterile, it must be handled in accordance with standard microbiology laboratory practices to prevent contamination during testing.
Can this test system be reused, and what storage requirements apply?
The ComASP Cefiderocol 0.008–128 is designed for single-use only. Storage should follow standard in vitro diagnostic procedures, though specific conditions (e.g., temperature, humidity) are not detailed in the data. Laboratories should refer to manufacturer guidelines for optimal storage to maintain test integrity.
What regulatory pathway does this device follow?
The ComASP Cefiderocol 0.008–128 is cleared under the FDA’s 510(k) pathway (K230479) as substantially equivalent to a predicate device. It is classified under device class II and regulated under 21 CFR 866.1640 for antimicrobial susceptibility testing systems. The decision was reviewed by the Microbiology Advisory Committee.
Does this system require special handling or compatibility considerations?
The system does not have MRI compatibility requirements. It is intended for use in microbiology laboratories and adheres to standard AST procedures. Handling should avoid contamination, as it is non-sterile, and follow manufacturer instructions for accurate results.