# K092445: Sensititre 18-24 Hour Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Ltd.
- Decided: Dec 16, 2009 after 128 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®g 18 -24 hour MIC or Breakpoint Susceptibility System" is an in vitmo diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) Isfor addition of Minocycline Inthe dilution range of 0.03 - 32pgImi for testing gram negative and gram positive Isoiates on the SensititreV 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline isfor: Aerobic and facultative Grain-negative and Gramn-positive microorganisms: Escherlchla coill KMebstella spp. Enterobacter aerogenes Aclnetobacterspp. Staphylococcusaureus* *Minocyciine Ls not the drug of choice in the treatment of any type of staphylococcal infection.

Source page: https://510kreport.com/device/K092445
Methodology: https://510kreport.com/methodology