# K251580: MTS Sulbactam-Durlobactam  0.004/4 - 64/4 µg/mL (SUD)

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Aug 20, 2025 after 89 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
Longest line of descent: 1 generation back to K153687 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL, Liofilchem s.r.l. (2016) Summary page 5.

## Indications for use
The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 pug/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in pg/ml of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 ng/ml should be interpreted at 16-20 hours of incubation. Testing with MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 pg/mL is indicated for Acinetobacter baumannii calcoaceticus complex as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The MTS Sulbactam-Durlobactam 0.004/4-64/4 pg/mL has demonstrated acceptable performance with the following organisms: Acinetobacter baumannii calcoaceticus complex

Source page: https://510kreport.com/device/K251580
Methodology: https://510kreport.com/methodology