510(k) · Cleared
ClearedMicroscan Dried Gram Negative Mic/Combo Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Jul 18, 2006 as substantially equivalent to K013423 (Dade Microscan, Inc., 2001) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 18, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013423 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK013423 Microscan Dried Gram Negative Overnight Mic/Combo PanelsDade Microscan, Inc. · 2001
- This deviceK061536 Microscan Dried Gram Negative Mic/Combo PanelsDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013423 | Microscan Dried Gram Negative Overnight Mic/Combo Panels | Dade Microscan, Inc. | 2001 | — |
| 0 (this device) | K061536 | Microscan Dried Gram Negative Mic/Combo Panels | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013423 | Microscan Dried Gram Negative Overnight Mic/Combo PanelsSummary page 1…-Lactamase production in Escherichia coli, Klebsiella spp. and Proteus mirabilis. S10(k) Notification: Modification to k013423- ESBL Screen Modification to k020037- ESBL Confirmation Predicate device: M… | 2001 |
| * | K020037 | Dried Gram Negative Mic/Combo PanelsSummary page 1…coli, Klebsiella spp. and Proteus mirabilis. S10(k) Notification: Modification to k013423- ESBL Screen Modification to k020037- ESBL Confirmation Predicate device: MicroScan" Dried Gram Negative Panels 510(k) Summary: MicroScan®… | 2002 |
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.
What does this lineage say?
- None of the 2 ancestors has a 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 MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. colt, Klebsiella spp and P. mirabilis. The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly…
Read the full statement (214 words)
The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. colt, Klebsiella spp and P. mirabilis.
The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.
After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO 2 incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 [igml), ceftazidime (0.5-128 kig/ml) and cefotaxime (0.5-128 Itg/ml) for ESBL screening, and for the anthiicrobics ceftazidime (0.5-128 gtg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 _tg/ml), cefotaximne (0.5-128 !tg/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 jig/ml) for ESBL confirmation.
The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichiacoli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichiacoli
Klebsiella oxytoca
Klebsiellapneumoniae
Proteus mirabilis
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/K061536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061536: Microscan Dried Gram Negative Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061536
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026