# K024357: Sensititre 18-24 Hour Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Mar 17, 2003 after 77 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- 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 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Gatifloxacin in the dilution range of 0.008 - 16 pg/rnl to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary “Indications for Use“ and clinical significance of Gatifloxacin is for: Escherichia coli, Klebsiellapiteumoniae, Proteus mirabilis. In vitro data, without clinical correlation is provided for: Acinetobacter lwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris

Source page: https://510kreport.com/device/K024357
Methodology: https://510kreport.com/methodology