# K033522: Sensititre 18-24 Hours Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Feb 3, 2004 after 88 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 organisms. This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 - 64 jig/ml to the Sensititre 18 -24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcusfaecalis (vancomycin-susceptible strains only), Streptococcus agalactiaeand Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.

Source page: https://510kreport.com/device/K033522
Methodology: https://510kreport.com/methodology