# K040846: Sensititre Haemophilus/Streptococcus Pneumoniae (HP) Mic Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Apr 26, 2004 after 25 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 H. influenzae/S. pneumoniae. This 510(k) is for the addition of Ertapenem in the dilution range of 0.008-16gg/mi to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Ertapenem is for: Streptococcus pneumoniae ( penicillin susceptible strains only) and Haemophilus influenzae (Beta-lactamase negative strains only). In vitro data, without clinical correlation is provided for: Streptococcus pneumoniae (penicillin-intermediate strains only) and Haemophilus influenzae (Beta-lactamase positive strains)

Source page: https://510kreport.com/device/K040846
Methodology: https://510kreport.com/methodology