# K143381: Sensititre Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Feb 19, 2015 after 86 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 HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the addition of newly approved Dalbavancin for the dilution range of 0.0005-2ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary “Indications for Use” and clinical significance for Streptococcus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus

Source page: https://510kreport.com/device/K143381
Methodology: https://510kreport.com/methodology