510(k) · Cleared
Recalled · Class II · 2015Microscan Microstrep Plus Panel New Antimicrobial-Penicillin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Microscan, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial
Cleared on Apr 26, 2002 as substantially equivalent to K963641 (Dade Microscan, Inc., 1996) after a 59-day review. Its family tree reaches back 1 generation to 1996. It has been recalled 2 times.
- Decided
- Apr 26, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- LTT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963641 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
- This deviceK020626 Microscan Microstrep Plus Panel New Antimicrobial-PenicillinDade Microscan, Inc. · 2002
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) | K020626 | Microscan Microstrep Plus Panel New Antimicrobial-Penicillin | Dade Microscan, Inc. | 2002 | — |
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 LTT? 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 LTT device
- #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 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 |
|---|---|---|---|
| * | 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 plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2015 | Class II | Z-0108-2016 | Equipment maintenance | Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results. |
| Sep 10, 2015 | Class II | Z-0109-2016 | Equipment maintenance | Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 21 other devices also cite its predicate K963641.
How does its category compare?
All LTT devicesLTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTT
219in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LTT
7in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTT
3in 2017
MAUDE reports naming product code LTT, 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 | 7 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 1 | — | 7 | 10 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 4 | 132 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 4 | 90 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 219 | 0 | 0 |
| 2026 | 0 | — | 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 Penicillin at concentrations of 0.015 to 16 mcg/ml to the test panel
The organisms which may be used for Penicillin susceptibility testing in this panel are:
Streptococcus pneumoniae
Streptococci (Groups A, C, G, H, L and M)
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/K020626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020626: Microscan Microstrep Plus Panel New Antimicrobial-Penicillin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020626
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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