# K062022: Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Sep 11, 2006 after 56 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 in/luenzae/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 species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 - 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus infiuenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of azithromycin is for: Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococci (Groups C, F, G) Viridans group streptococci. The approved primary "indications for use" and clinical significance of amoxicillin/clavulanic acid 2:1 ratio is for: Streptococcus pneumoniae * * The following in vitro data are available but their clinical significance is unknown: Streptococcus pyogenes** "*Theseare non beta lactamase producing organisms, and therefore are susceptible to amoxicillin alone. The approved primary "indications for use" and clinical significance of cefotaxime is for: Streplococcuspneumnoniae Streptococcuspyogenes Streptococcus spp.

Source page: https://510kreport.com/device/K062022
Methodology: https://510kreport.com/methodology