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 21, 2006 as substantially equivalent to K020037 (Dade Microscan, Inc., 2002) after a 36-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jul 21, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020037 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020037 Dried Gram Negative Mic/Combo PanelsDade Microscan, Inc. · 2002
- This deviceK061687 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 | K020037 | Dried Gram Negative Mic/Combo Panels | Dade Microscan, Inc. | 2002 | — |
| 0 (this device) | K061687 | Microscan Dried Gram Negative Mic/Combo Panels | Dade Behring, Inc. | 2006 | — |
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? (1)
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 |
|---|---|---|---|
| * | K020037 | Dried Gram Negative Mic/Combo PanelsSummary page 1…Beta-Lactamase production in Escherichia cohi, Klebsiella spp. and Proteus mirabilis. 510(k) Notification: Modification to k020037- ESBL Confirmation Predicate device: MicroScan® Dried ESBL plus ESBL Confirmation Panel 510(k) Summary: Micr… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K020037.
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 Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichiacoli, Klebsiella spp. and Proteus mirabilis. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO₂ incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert. This particular submission is for the use of cefotaxime (2, 16 jig/ml)…
Read the full statement (248 words)
The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichiacoli, Klebsiella spp. and Proteus mirabilis.
After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO₂ incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert.
This particular submission is for the use of cefotaxime (2, 16 jig/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 jig/ml), ceftazidime (1, 8 tg/ml) and ceftazidine/clavulanic acid (0.25/4, 2/4 jig/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods.
The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichtia cobi
Kiebsiella oxytoca
Klebvielta pneumoniiae
Proreus nirabilii
The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamnase (ESBL) production in Escherichiacoli, Kiebsiella spp. and Proteus mirabilis.
After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO₂ incubator and read either visually or with MicroScan® instrumentation, according to the Package Insert.
This particular submission is for the use of cefotaxime (2, 16 jig/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 jig/ml), ceftazidime (1, 8 ltg/ml) and ceftazidime/clavulanic acid (0.25/4, 2/4 ltig/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods.
The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Litcherichia co/i
Kiebsiella Oxytoca
Klebsielia p'ietmonice
Proteus inbiisazt
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061687: Microscan Dried Gram Negative Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061687
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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