# K062722: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Oct 20, 2006 after 38 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 (HP) MIC Susceptibility/plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spp to Cefuroxime (0.5 -4 ug/mL), Gatifloxacin (1-8 ug/mL), Erythromycin (0.25-2 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Cefuroxime is for: Streptococcus pneumoniae, Streptococcus pyogenes The approved primary "indications for use" and clinical significance of Gatifloxacin is for Streptococcus pneumoniae, Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci Streptococcus agalactiae The approved primary "indications for use" and clinical significance of Erythromycin is for: Streptococcus pneumoniae Streptococcus pyogenes

Source page: https://510kreport.com/device/K062722
Methodology: https://510kreport.com/methodology