510(k) · Cleared
ClearedMicroscan Microstep Plus Panel New Antimicrobial - Vancomycin
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 May 8, 2002 as substantially equivalent to K963641 (Dade Microscan, Inc., 1996) after a 56-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- May 8, 2002
- Review
- 56 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963641 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
- This deviceK020822 Microscan Microstep Plus Panel New Antimicrobial - VancomycinDade Behring, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK062290 Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 MCG/ML)Dade Behring, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062290Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 MCG/ML)Dade Behring, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963641 | Streptococcus Mic Panel | Dade Microscan, Inc. | 1996 | — |
| 0 (this device) | K020822 | Microscan Microstep Plus Panel New Antimicrobial - Vancomycin | Dade Behring, Inc. | 2002 | — |
| +1 | K062290 | Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 MCG/ML) | Dade Behring, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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
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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 |
|---|---|---|---|
| * | K963641 | Streptococcus Mic PanelSummary page 1…n for Use For determining antimicrobic susceptibility with aerobic streptococci, including Streptococcus pneumoniae Predicate device: MicroScan® Streptococcus MIC Panel (K963641). 510(k) Summary: The MicroScan® MICroSTREP p/us™ Panel is used to determine quantitative and/or qualitative antimicrobial agent… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062290 | Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 MCG/ML) | 2006 | 0 |
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?
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® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 — 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Vancomycin at…
Read the full statement (103 words)
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 — 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Vancomycin at concentrations of 0.06 to 8 mcg/ml to the test panel
The organisms which may be used for Vancomycin susceptibility testing in this panel are:
Streptococcus pneumoniae (including penicillin-resistant strains)
Streptococcus pyogenes
Streptococcus agalactiae
the viridans group
Streptococcus bovis
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/K020822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020822: Microscan Microstep Plus Panel New Antimicrobial - Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020822
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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