# K110331: Sensititre Aim (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Apr 27, 2011 after 83 days
- Product code: LIE (Reagent/Device, Inoculum Calibration)
- 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® AIMTM is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP 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.

Source page: https://510kreport.com/device/K110331
Methodology: https://510kreport.com/methodology