# K083606: Sensititre 18-24 Hour Suseceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Mar 24, 2009 after 109 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® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16jig/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia co/i Kiebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcusaureus* *Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Source page: https://510kreport.com/device/K083606
Methodology: https://510kreport.com/methodology