# K110583: Sensititre Optiread

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Sep 22, 2011 after 205 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® OptiReadTM is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiReadTM is a fluorescence based detection instrument used to read Sensititre® MIC or B3P Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms. NOTE: Please refer to the Sensititre ® 18-24 hour MIC or Breakpoint Susceptibility System package insert or operator's manual for additional instructions, limitations and references. This 510(k) is for the addition of: "Sensititre® OptiReadTm" The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

Source page: https://510kreport.com/device/K110583
Methodology: https://510kreport.com/methodology