Liofilchem MIC Test Strip (MTS) – Tedizolid 0.002–32 µg/mL
510(k) K170892
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170892 | Date25 May 2017 | 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- Withdrawn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 Liofilchem MIC Test Strip (MTS) – Tedizolid 0.002–32 µg/mL is a manual antimicrobial susceptibility test system designed for determining the minimum inhibitory concentration (MIC) of tedizolid phosphate against microorganisms. It features a predefined concentration gradient of the antibiotic impregnated on high-quality paper, spanning 15 two-fold dilutions from 0.002 to 32 µg/mL, enabling precise susceptibility assessment.
This test strip is supplied in packs of 10 and requires incubation for 16–20 hours for nonfastidious organisms or 20–24 hours for fastidious organisms before interpretation. It is intended for use in microbiology laboratories and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (21 CFR 866.1640). No sterility or single-use specifications are stated in the regulatory data.
Other devices from Liofilchem S.r.l.
Questions
AI-generated answers, 19 Sep 2026
What is the Liofilchem MIC Test Strip (MTS) – Tedizolid 0.002–32 µg/mL used for in a clinical setting?
This test strip is designed specifically for determining the minimum inhibitory concentration (MIC) of tedizolid phosphate against microorganisms in microbiology laboratories. It provides a gradient of 15 two-fold dilutions (0.002 to 32 µg/mL) to assess how susceptible bacteria are to tedizolid, helping guide appropriate antibiotic treatment decisions.
How many test strips are included in a single pack, and what is the recommended incubation time?
Each pack contains 10 test strips. The recommended incubation time varies by organism type: 16–20 hours for nonfastidious organisms and 20–24 hours for fastidious organisms before interpreting results.
Is the Liofilchem MIC Test Strip (MTS) – Tedizolid intended for single-use or reusable applications?
The regulatory data does not explicitly state whether the strips are single-use or reusable. However, given that MIC test strips are typically designed for one-time use per sample to ensure accuracy and prevent cross-contamination, it is reasonable to assume single-use unless otherwise specified by the manufacturer.
What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?
The device received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device (21 CFR 866.1640). This classification is common for antimicrobial susceptibility test systems, which are considered moderate-risk devices.
Are there any specific storage instructions mentioned for the Liofilchem MIC Test Strip (MTS) – Tedizolid?
The provided data does not include explicit storage instructions. Typically, antimicrobial susceptibility test strips should be stored in a cool, dry place, protected from light and moisture, but you should refer to the manufacturer’s instructions for precise guidance.