# K011803: Sensititre 18 - 24 Hours Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Aug 15, 2001 after 65 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 disgnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Streptomyein in the concentrations of 1000ug/mi and 2000pg/ral to the Sensititre 18-24 hour MIC panel for use as 2 Screening Test for High-Level Aminoglycoside Resistance, HLAR, in Enterococcus spp. "Indications for Use" and clinical significance of Streptomycin is for: Enterococeus species.

Source page: https://510kreport.com/device/K011803
Methodology: https://510kreport.com/methodology