# K111429: Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the Sensititre (R) 18-24 Hour Mic Susce...

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Aug 18, 2011 after 87 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 1, 2025 · Class II · Z-1947-2025: Product may have an off color affecting perfomance

## Indications for use
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 -24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates. This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8jg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 - 24 hour MIC panel in the dilution range of O.06-64[t§/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are: Facultative Gram-Positive Microorgqanisms. Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus egalattle Streptococcus pneurnoniae

Source page: https://510kreport.com/device/K111429
Methodology: https://510kreport.com/methodology