# K143288: Sensititre Susceptibility plates

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Apr 1, 2015 after 135 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 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8 ug/m! for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary “Indications for Use” and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis(vancomycin-susceptible isolates only)

Source page: https://510kreport.com/device/K143288
Methodology: https://510kreport.com/methodology