# K062190: Sensititre Haemophilus / Streptococcus Pneumoniae (HP) Mic Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Aug 31, 2006 after 31 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. The FDA summary names no predicate by number.

## Indications for use
The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 gg/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-postive microorganisms Streptoccus agalactiae Streptococcus pyogenes Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and. S. constellatus)

Source page: https://510kreport.com/device/K062190
Methodology: https://510kreport.com/methodology