# K183324: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Feb 15, 2019 after 77 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 Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes

Source page: https://510kreport.com/device/K183324
Methodology: https://510kreport.com/methodology