# K014259: Sensititre Heamophilus/Streptococcus Pneumoniae (HP) Mic Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Mar 26, 2002 after 90 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 Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the removal of the statement in our package insert under Plate Reading and Interpretation of Results: "The panel may only be read manually.” Replace this statement with "The panel may be autoread or manually read when testing S. pneumoniae and manually read with Haemophilus." The Sensititre Haemophilus/Streptoceccus pneumoniae MIC panel is for testing Streptococcus pneumoniae and Haemophilus influenzae isolates.

Source page: https://510kreport.com/device/K014259
Methodology: https://510kreport.com/methodology