510(k) · Cleared
Recalled · Class II · 2015Microscan Microstrep Plus, Model B1027-201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LTT Panels, Test, Susceptibility, Antimicrobial
Cleared on Jan 26, 2010 after a 209-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Jan 26, 2010
- Review
- 209 days
- Class
- Class II
- Product code
- LTT
- Recalls
- 3
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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- #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 |
|---|---|---|---|
| * | — | MicroScan® MICroSTREP plus®Panels Named without a submission number |
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. |
| Mar 6, 2013 | Class II | Z-1272-2013 | Under Investigation by firm | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LTT devicesLTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 MicroScano MICroSTREP pluso 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 350 C +/- 1 C in a non-CO2 incubator, and read either visually or with MicroScan® WalkAway instrument. This particular submission is-for the evaluation of antimicrobial agent…
Read the full statement (122 words)
The MicroScano MICroSTREP pluso 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 350 C +/- 1 C in a non-CO2 incubator, and read either visually or with MicroScan® WalkAway instrument.
This particular submission is-for the evaluation of antimicrobial agent penicillin on the MicroScan® MIC~roSTREP plus® Panel utilizing the updated Streptococcuspneumoniae meningitis interpretative criteria (S <0006, R> 0. 12) and non-meningitis interpretative criteria (S <2, 1 =4 R Ž8).
The organisms which may be used for Penicillin susceptibility testing in this panel are:
Streptococcuspneumoniae
Streptococci (Groups A, C, G, H, L and M)
Streptococcus agalactiae
Viridans Streptococci
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091949: Microscan Microstrep Plus, Model B1027-201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091949
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026