# K022656: Sensititre 18-24 Hours Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Oct 8, 2002 after 60 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 negative and gram positive organisms. This 510(k) is for the elimination of limitations in the Sensititre technical insert. The limitation to be removed are as follows: 1) The AutoReader system should not be used to read coagulase-negative Staphylococcus species as they will not generate adequate signal to give a susceptibility result. Such strains should be read manually. Maintain limitation 8 with a modification: Staphylococcus species tested against Penicillin G should also be tested for Beta-lactamase production, especially in strains with borderline MICs (0.06–0.25 μg/ml). If these strains test Beta-lactamase positive, a repeat test should be done to ensure resistance is reported. The addition of the following limitation in the Sensititre Technical Insert: The Autoreader system should not be used to read SXT with CNS. SXT should be read manually.

Source page: https://510kreport.com/device/K022656
Methodology: https://510kreport.com/methodology