# K062681: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Oct 13, 2006 after 35 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 infiuenzae/Streptococculs 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 cefepime (0.12 - 8 ug/mL), ceftriaxone (0.06-2 ug/mL), chloramphenicol (2-16 ug/mL) for use with the Sensititre® Haemophilus influenzaelStreptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of cefepime is for: Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae The approved primary "indications for use" and clinical significance of ceftriaxone is for Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Streptococcus agalactiae The approved primary "indications for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae Streptococcus spp.

Source page: https://510kreport.com/device/K062681
Methodology: https://510kreport.com/methodology