510(k) · Cleared
ClearedSensititre Optiread
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Ltd. · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Sep 22, 2011 after a 205-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 22, 2011
- Review
- 205 days
- Class
- Class II
- Product code
- LRG
- 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 LRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 LRG devicesLRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LRG
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LRG
144in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRG
1in 2025
MAUDE reports naming product code LRG, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 4 | 144 | 0 | 11 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sensititre® OptiReadTM is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiReadTM is a fluorescence based detection instrument used to read Sensititre® MIC or B3P Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms. NOTE: Please refer to the Sensititre ® 18-24 hour MIC…
Read the full statement (144 words)
The Sensititre® OptiReadTM is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiReadTM is a fluorescence based detection instrument used to read Sensititre® MIC or B3P Susceptibility plates.
The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.
NOTE: Please refer to the Sensititre ® 18-24 hour MIC or Breakpoint Susceptibility System package insert or operator's manual for additional instructions, limitations and references.
This 510(k) is for the addition of: "Sensititre® OptiReadTm"
The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110583: Sensititre Optiread.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110583
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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