510(k) · Cleared
ClearedMicroscan Dried Gram Negative Mic/Combo Panels , Esbl Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Microscan, Inc. · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Nov 18, 1998 after a 230-day review. The FDA summary names no predicate by number.
- Decided
- Nov 18, 1998
- Review
- 230 days
- Class
- Class II
- Product code
- LRG
- 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 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?
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 LRG devicesLRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Panels containing Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to screen for Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).
An alternate method is required for confirmation testing.
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/K981199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981199: Microscan Dried Gram Negative Mic/Combo Panels , Esbl Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981199
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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