# K053243: Sensititre 18-24 Hours Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Jan 20, 2006 after 60 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 Gemifloxacin in the dilution range of 0.002 - 16 gg/ml for testing gram positive and 0.002- 4 jig/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for: Klebsiella pneumonia. Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25jig/mL) or less against most (Ž>90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris.

Source page: https://510kreport.com/device/K053243
Methodology: https://510kreport.com/methodology