# K073558: Sensititre 18-24 Susceptibility Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Mar 13, 2008 after 85 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 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Cefoxitin Screen" The "Cefoxitin Screen (66pg/ml) " can be used to predict the presence of mecA-mediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of < = 6 (no growth) should be reported as oxacillin susceptible.

Source page: https://510kreport.com/device/K073558
Methodology: https://510kreport.com/methodology