# K022775: Sensititre 18-24 Hours Susceptibility Plates

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Sep 25, 2002 after 47 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 51O(k) is for the elinunation of liniitations in the sensititre technical insert. The limitation to be reniovcd are as follows: 2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillidclavulanic acid with Enterococcus sp., and gentamicin (500 pg/mL) with Enterococcus faecium is unknown because too few resistant strains were available at the time of comparative testing. The addition of the following limitation in the Sensititre technical insert: The autoreader system should not be used to read Nitrofurantoin with Enterococcus species. Nitrohrantoin should be read manually. The ability to detect resistance with nitrobntoin is unknown because too few resistant strains were available at the time of comparative testing.

Source page: https://510kreport.com/device/K022775
Methodology: https://510kreport.com/methodology