# K060783: Susceptibility Test Plate for Vancomycin Vrsa Limitation Removal

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: May 16, 2006 after 55 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 the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is: ' The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that SHI agar supplemented with 6pg/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC.' Then the following statement would be added to the technical insert: Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.

Source page: https://510kreport.com/device/K060783
Methodology: https://510kreport.com/methodology