# K073653: Sensititre 18 - 24 Hour Susceptibility Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Mar 20, 2008 after 85 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K082538: BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test (2008), 0 descendants of its own

## 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 the addition of: "Dtest" The Dtest for Broth Microdilution Test is for Staphylococcus spp. resistant to (MIC's > 8ug/ml) erythromycin and susceptible or intermediate (MIC's < 2ug/ml) to clindamycin. With these isolates a Dtest 1 (4/0.5 ug/ml) or 2 (8/1.5 ug/ml) or both 1 and 2 are positive (growth) the test should be reported as inducible clindamycin resistance. If with these isolates there is no growth in both Dtest 1 and 2 the isolates should be reported as negative for inducible resistance.

Source page: https://510kreport.com/device/K073653
Methodology: https://510kreport.com/methodology