# K181889: MTS Penicillin 0.002- 32 µg/mL

- Pathway: 510(k) (Traditional)
- Applicant: Liofilchem s.r.l.
- Decided: Sep 13, 2018 after 62 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Liofilchem® MTS™ (MIC Test Strip) Penicillin 0.002-32 pg/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. The MTS™ Penicillin at concentrations of 0.002 - 32 ug/mL should be interpreted at 20-24 hours of incubation for Streptococcus spp. MTS™ Penicillin can be used to determine the MIC of penicillin against the following bacteria. Penicillin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Streptococcus pneumoniae Streptococcus pyogenes (Group A ) Streptococcus dysgalactiae (Groups C & G) Streptococcus anginosus (Groups C & G) Streptococcus constellatus (Groups C & G) Streptococcus intermedius (Groups C & G)

Source page: https://510kreport.com/device/K181889
Methodology: https://510kreport.com/methodology