510(k) · Cleared
ClearedMicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/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 Sep 16, 2015 as substantially equivalent to K150039 (Siemens Healthcare Diagnostics, Inc., 2015) after a 27-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 16, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003619 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK003619 Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 2001
- 2 generations backK123933 Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineSiemens Healthcare Diagnostics, Inc. · 2013
- 1 generation backK150039 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin…Siemens Healthcare Diagnostics, Inc. · 2015
- This deviceK152346 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64…Beckman Coulter, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003619 | Dried Gram-Positive Mic/Combo Panels | Dade Microscan, Inc. | 2001 | — |
| −2 | K123933 | Microscan Dried Gram-Positive Mic/Combo Panels - Ceftaroline | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| −1 | K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| 0 (this device) | K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) | Beckman Coulter, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)Summary page 4…ct Code: LTT 510(k) Notification: Antimicrobial agent - Vancomycin Predicate device: MicroScan Dried Gram-Positive MIC/Combo Panels – Vancomycin (K150039) 510(k) Summary: MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative… | 2015 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K150039.
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. 2015, 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® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. 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…
Read the full statement (115 words)
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. 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 addition of the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 μg/ml to the test panel.
The gram-positive organisms which may be used for Vancomycin susceptibility testing in this panel are:
Enterococci (e.g., Enterococcus faecalis)
Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152346: MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152346
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