# K140985: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jun 10, 2014 after 55 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 Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Clindamycin in the dilution range of 0.015-1 µg/ml to the Sensititre HP MIC susceptibility plate for testing Streptococcus species. The approved primary "Indications for Use" and clinical significance of Clindamycin is for: Facultative Gram-Positive Fastidious Microorganisms: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus

Source page: https://510kreport.com/device/K140985
Methodology: https://510kreport.com/methodology