# K062839: Modification to Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Nov 9, 2006 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 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 spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Tetracycline is for: Streptococcus pneumoniae Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci Streptococcus (beta-hemolytic group ) Trimethoprim/Sulphamethoxazole is for Streptococcus pneumoniae Vancomycin is for: Streptococcus preumoniae Streptococcus pyogenes Viridans group streptococci Streptococcus agalactiae Streptococcus (beta-hemolytic group )

Source page: https://510kreport.com/device/K062839
Methodology: https://510kreport.com/methodology