510(k) · Cleared
ClearedSusceptibility Test Plate for Vancomycin Vrsa Limitation Removal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on May 16, 2006 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 16, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWY device
- #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (207 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060783 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060783: Susceptibility Test Plate for Vancomycin Vrsa Limitation Removal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026