# K093865: Sensititre 18-24HR Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Feb 17, 2010 after 63 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. The FDA summary names no predicate by number.

## 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 non fastidious isolates. This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2 μg/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 0.03-16 μg/ml for testing Gram positive clinical isolates. The approved primary "Indications for Use" and clinical significance of positive isolates. Telavancin is for: * Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) In vitro data, without clinical correlation is provided for: * Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp. equisimilis Staphylococcus epidermidis

Source page: https://510kreport.com/device/K093865
Methodology: https://510kreport.com/methodology