# K093741: Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Feb 25, 2010 after 83 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® Haernophilusinfluenza/Streptococcuspneumoniae (HP) MIC susceptibility plates and JustOne®~ are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemnophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - S gg/IMI for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use' and clinical significance of Tigecycline is for: Aerobic facultative Gram-positive microorganisms Streptococcus jpneuinoniae (Penicillin susceptible stains only)

Source page: https://510kreport.com/device/K093741
Methodology: https://510kreport.com/methodology