Liofilchem MIC Test Strip (MTS) Ceftolozane/Tazobactam 0.016/4 – 256/4 mcg/mL
510(k) K161175
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161175 | Date12 Jul 2016 | 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- Withdrawn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, 20 Sep 2026
The Liofilchem MIC Test Strip (MTS) Ceftolozane/Tazobactam 0.016/4 – 256/4 mcg/mL is a manual antimicrobial susceptibility test system designed for in vitro determination of bacterial susceptibility. It falls under the category of quantitative antimicrobial susceptibility testing, providing a gradient of ceftolozane concentrations (ranging from 0.016 to 256 mcg/mL) in the presence of a fixed concentration of tazobactam (4 mcg/mL). This device aids microbiologists in assessing the minimum inhibitory concentration (MIC) of antimicrobial agents against bacterial isolates, facilitating informed treatment decisions. The test strip generates a stable concentration gradient, enabling precise measurement of bacterial resistance or susceptibility profiles.
This device is supplied as a single-use test strip and is intended for use in clinical microbiology laboratories. It is not sterile and must be handled in accordance with standard microbiological practices to prevent contamination. The test strips are available in packages of 10, 30, or 100 tests, as referenced in regulatory filings. The device holds an FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (Device Class 2) under regulation number 866.1640. Compliance with microbiology laboratory protocols and adherence to manufacturer instructions are essential for accurate results.
Other devices from Liofilchem S.r.l.
Questions
AI-generated answers, 20 Sep 2026
What is the Liofilchem MIC Test Strip Ceftolozane/Tazobactam used for in a clinical setting?
This device is designed for in vitro antimicrobial susceptibility testing to determine the minimum inhibitory concentration (MIC) of ceftolozane/tazobactam against bacterial isolates. By creating a gradient of ceftolozane concentrations (0.016–256 mcg/mL) with a fixed tazobactam concentration (4 mcg/mL), it helps microbiologists assess bacterial resistance or susceptibility, guiding targeted antibiotic treatment decisions in clinical microbiology labs.
How are the test strips packaged and how many can I order at once?
The strips are supplied in single-use formats, available in packages of 10, 30, or 100 tests—allowing flexibility for lab workflows. Each strip must be used once and discarded to avoid contamination, as it is not sterile and requires adherence to standard microbiological handling practices.
Is this device approved for use in the U.S.? If so, what regulatory pathway was followed?
Yes, the Liofilchem MIC Test Strip holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (regulation number 866.1640). The clearance was granted in 2016 after demonstrating substantial equivalence to a predicate device, with review by the Microbiology (MI) Advisory Committee.
Can these strips be reused, or do they require special storage conditions?
The strips are single-use only and must not be reused to prevent contamination or inaccurate results. While not explicitly labeled as sterile, they must be handled in a clinical microbiology lab following standard aseptic practices. Storage conditions are not detailed in the data, but typical lab protocols for antimicrobial susceptibility test strips (e.g., dry, protected from light) should apply.