# K223844: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Mar 21, 2023 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
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 Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 µg/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 µg/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp. For Community Acquired Bacterial Pneumonia (CABP) Streptococcus pneumoniae Haemophilus influenzae

Source page: https://510kreport.com/device/K223844
Methodology: https://510kreport.com/methodology