510(k) · Cleared
ClearedSensititre 18-24 HR Susceptibility Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Nov 8, 2011 after a 151-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 8, 2011
- Review
- 151 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
- #3 Held for the reportin the report
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. 2011, this device’s year, is highlighted.
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 HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.O15-S4ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System. The Sensititre HP MIC Susceptibility plate isan in vitro diagnostic product for clinical susceptibility testingoffahtidiasisiioat-es. The S-eniiititre I78_2T4_Foufl lC or B-re-akp-int Susc-tibiiW System isa…
Read the full statement (190 words)
The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.O15-S4ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System. The Sensititre HP MIC Susceptibility plate isan in vitro diagnostic product for clinical susceptibility testingoffahtidiasisiioat-es. The S-eniiititre I78_2T4_Foufl lC or B-re-akp-int Susc-tibiiW System isa -n in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) isfor the addition of Ceftaroline in the dilution range of .OlS-32pt/mI to the Sensititre HP MIC Susceptibility plate for testing Hoemaphilus influenzae and the Sensititre 18-24 hour MIC panel in the dilution range of 0.015-G4gig/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline isfor:
Facultative Gram-negative Microorganisms:
Escherichia co/i
Klebsiella preumoniae
Kiebsiellaoaxytoca
Haemaphdlus influenzae
in vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri
Citrobacterfreundii
Enteroacter cloacae
Enteroacter aera genes
Moraxella catarrhlis
Morganeila morganll
Proteus mirabilis
Ceftaroline isnot active against Gram negative bacteria producing extended spectrum beta-lactamases (ESB~s) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC) class Bmetallo-beta-lactamases or class C(AmpC cephalosporinases).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111615: Sensititre 18-24 HR Susceptibility Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111615
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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