510(k) · Cleared
ClearedMicroscan Synergies Plus Gram Negative Mic/Combo Panels with Cephalothin (0.5-32 UG/ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Apr 2, 2004 after a 317-day review. The FDA summary names no predicate by number.
- Decided
- Apr 2, 2004
- Review
- 317 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LON? 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 LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
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 LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, 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 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
The MicroScan® rapID/S plus Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 — 18 hours at 35°C +/- 1°C, in a WalkAway® S/ or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a…
Read the full statement (157 words)
The MicroScan® rapID/S plus Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 — 18 hours at 35°C +/- 1°C, in a WalkAway® S/ or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CQO, incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cephalothin, at concentrations of 0.5 to 32 pg/ml, to the test panel.
The gram-negative organisms which may be used for Cephalothin susceptibility testing in this panel are:
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
The MicroScan® Gram rapID/$ plus Gram-Negative Panels with Cephalothin is not intended for use with:
Klebsiella oxytoca Proteus penneri
Enterobacter spp. Providencia spp
Citrobacter freundii Serratia spp.
Morganella morganii Yersinia enterolitica
Proteus vulgaris
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031601: Microscan Synergies Plus Gram Negative Mic/Combo Panels with Cephalothin (0.5-32 UG/ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031601
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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