# K141000: Sensititre Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jul 16, 2014 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 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 Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious Gram positive isolates. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resiscant isolates) Enterococcus faecalis

Source page: https://510kreport.com/device/K141000
Methodology: https://510kreport.com/methodology