510(k) · Cleared
ClearedMicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on May 18, 2021 as substantially equivalent to K020939 (Dade Microscan, Inc., 2002) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 18, 2021
- Review
- 266 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963641 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963641 | Streptococcus Mic Panel | Dade Microscan, Inc. | 1996 | — |
| −1 | K020939 | Microscan Microstrep Plus Panel-Tetracycline | Dade Microscan, Inc. | 2002 | — |
| 0 (this device) | K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) | Beckman Coulter, Inc. | 2021 | — |
Other ancestors 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
- #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 |
|---|---|---|---|
| * | K020939 | Microscan Microstrep Plus Panel-TetracyclineSummary page 3…moniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 — 16 pg/mL on the MicroScan MICroSTREP plus Panel (modification to K020939 and K062923). Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as describe… | 2002 |
| * | K062923 | Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 MCG/ML)Summary page 3…ptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 — 16 pg/mL on the MicroScan MICroSTREP plus Panel (modification to K020939 and K062923). Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA… | 2006 |
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 19.0 years on median.
- None of the 3 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. 2021, this device’s year, is highlighted.
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 and 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 MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway…
Read the full statement (146 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 and 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 MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 — 16 pg/mL on the MicroScan MICroSTREP plus Panel (modification to K020939 and K062923).
Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site.
Streptococcus spp.
Streptococcus pneumoniae
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/K202423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202423: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202423
Report an extraction error
Are you the manufacturer?
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