# K103456: The Sensititre Aim

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems
- Decided: Jun 22, 2011 after 210 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®D AIM' h is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM' h 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 gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp. NOTE: Please refer to the Sensititre ®D18-24 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: "AIM" The Sensititre AIMTM is a microprocessor controlled instrument that delivers inoculum in 50µl multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

Source page: https://510kreport.com/device/K103456
Methodology: https://510kreport.com/methodology