MTS Omadacycline 0.002 - 32 ug/mL
510(k) K200180
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200180 | Date20 Mar 2020 | 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- Withdrawn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, 19 Sep 2026
The MTS Omadacycline MIC Test Strip 0.002–32 µg/mL is a manual antimicrobial susceptibility test system designed for in vitro quantitative determination of bacterial susceptibility to omadacycline. Classified as a microbiology device under FDA product code JWY, it provides a gradient of antimicrobial concentrations to measure the minimum inhibitory concentration (MIC) of the agent against bacterial isolates.
This single-use, non-sterile test strip is intended for use in clinical microbiology laboratories. Supplied as a ready-to-use assay, it requires no additional preparation beyond standard microbiological procedures. The device is regulated under FDA 510(k) clearance (K200180) and falls under Class 2 medical devices, adhering to FDA regulation 866.1640 for microbiology test systems. Storage and handling follow standard laboratory protocols for antimicrobial susceptibility testing.
Other devices from Liofilchem S.r.l.
Questions
AI-generated answers, 19 Sep 2026
What is the MTS Omadacycline 0.002–32 µg/mL test strip used for in a clinical setting?
This test strip is designed for in vitro quantitative determination of bacterial susceptibility to omadacycline. It measures the minimum inhibitory concentration (MIC) of the antibiotic against bacterial isolates, helping laboratories assess how effective omadacycline may be against specific pathogens. The results guide treatment decisions by providing data on bacterial resistance patterns.
Is the MTS Omadacycline test strip sterile, and how should it be handled?
The MTS Omadacycline test strip is non-sterile and intended for single-use in clinical microbiology laboratories. Since it requires no additional preparation beyond standard microbiological procedures, it should be handled following general laboratory protocols for antimicrobial susceptibility testing, including proper storage and contamination control.
How is the test strip supplied, and what does ‘ready-to-use’ mean in this context?
The strip is supplied as a ready-to-use assay, meaning no further preparation (e.g., dilution or activation) is required beyond standard microbiological setup. Users simply apply it to a bacterial culture following established susceptibility testing protocols, allowing immediate use without additional manipulation.
What regulatory pathway does this device follow, and how does that affect its use?
The MTS Omadacycline test strip is cleared under FDA 510(k) (K200180) as a Class 2 medical device, classified under product code JWY for microbiology test systems. This clearance confirms it meets FDA standards for antimicrobial susceptibility testing, ensuring its reliability for clinical decision-making. The regulatory classification does not alter its intended use but assures compliance with U.S. medical device regulations.