# K111615: Sensititre 18-24 HR Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems
- Decided: Nov 8, 2011 after 151 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 HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.O15-S4ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System. The Sensititre HP MIC Susceptibility plate isan in vitro diagnostic product for clinical susceptibility testingoffahtidiasisiioat-es. The S-eniiititre I78_2T4_Foufl lC or B-re-akp-int Susc-tibiiW System isa -n in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) isfor the addition of Ceftaroline in the dilution range of .OlS-32pt/mI to the Sensititre HP MIC Susceptibility plate for testing Hoemaphilus influenzae and the Sensititre 18-24 hour MIC panel in the dilution range of 0.015-G4gig/ml for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Ceftaroline isfor: Facultative Gram-negative Microorganisms: Escherichia co/i Klebsiella preumoniae Kiebsiellaoaxytoca Haemaphdlus influenzae in vitro data, without clinical correlation is provided for: Facultative Gram-Negative Microorganisms: Citrobacter koseri Citrobacterfreundii Enteroacter cloacae Enteroacter aera genes Moraxella catarrhlis Morganeila morganll Proteus mirabilis Ceftaroline isnot active against Gram negative bacteria producing extended spectrum beta-lactamases (ESB~s) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC) class Bmetallo-beta-lactamases or class C(AmpC cephalosporinases).

Source page: https://510kreport.com/device/K111615
Methodology: https://510kreport.com/methodology