# K062783: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Oct 26, 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. The FDA summary names no predicate by number.

## Indications for use
The Sensititre® Haemophilus infiuenzae/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 spps. to Gemifloxacin (0.03 -0.5 ug/mL), Linezolid (0.5-4 ug/mL), Levofloxacin (0.5-16 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 Gemifloxacin is for: Streptococcus pneumoniae The following in vitro data are available but their clinical significance is unknown: Streptococcus pyogenes The approved primary "indications for use" and clinical significance of Linezolid is for Streptococcus pneumoniae, (including multi-drug resistant strains) Streptococcus agalactiae Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci The approved primary "indications for use" and clinical significance of Levoflioxacin is for: Streptococcus pneumoniae (including multi-drug resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci Streptococcus agalactiae Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus milleri

Source page: https://510kreport.com/device/K062783
Methodology: https://510kreport.com/methodology