# K052091: Sensitire Susceptibility Plates- Additional Antimicrobics

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Sep 21, 2005 after 50 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 Tigecycline in the dilution range of 0.008 - 16 pg/ml for testing gram positive and 0.015-16lig/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-postive microorganisms Enteroccus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptoccus agalactiae Streptococcus pyogenes Aerobic and facultative Gram-negative microorganisms Citrobacterfreundii Enterobacter cloacae Escherichia coil Klebsiella oxytoca Klebsiella pneumoniae In vitro data, without clinical correlation is provided for: Aerobic and facultative Gram-postive microorganisms Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistantisolates) Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates) Staphylococcus haemolyticus Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Aeromonas hydrophila Citrobacter koseri Enterobacteraerogenes Serratia marcescens Stenotrophomonas maltophilia

Source page: https://510kreport.com/device/K052091
Methodology: https://510kreport.com/methodology