# K041534: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Susceptibility Plate and Susceptibility Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Jul 27, 2004 after 49 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/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. This 510(k) is for the addition of Telithromycin in the dilution range of 0.002-16pg/mI to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haernophilus/Streptococcus pneumoniae and-the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSPi), Haemophilus influenzae. and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).

Source page: https://510kreport.com/device/K041534
Methodology: https://510kreport.com/methodology