# K031545: Sensititre 18-24 Hour Susceptibility Plate

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Jul 16, 2003 after 61 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K033458: BD Phoenix Automated Microbiology System - Confirmatory Esbl Test (2004), 1 descendant of its own
- K181665: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN (2018), 0 descendants of its own

## Indications for use
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre@ ARIS or Autoreader. This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella meumoniae, Klebsiella oxvtoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7): Ceftazimdime: 0.06-128 Ceftazidime/clavulanic acid: 0.06/4-128/4 Cefotaxime: 0.06-64 Cefotaxime/clavulanic acid: 0.06/4-64/4

Source page: https://510kreport.com/device/K031545
Methodology: https://510kreport.com/methodology