510(k) · Cleared
ClearedMicroscan (R) Microstrep Plus (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Aug 4, 2011 as substantially equivalent to K020556 (Dade Microscan, Inc., 2002) after a 50-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 4, 2011
- Review
- 50 days
- Class
- Class II
- Product code
- LRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963641 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K020556 | Microscan Microstrep Plus Panel with LevofloxacinSummary page 5…se: To determine antimicrobial agent susceptibility 510(k) Notification: New antimicrobial - Linezolid Predicate device: MicroScan MICroSTREP plus Panels ~ Levofloxacin (K020556) 510(k) Summary: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrob… | 2002 |
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 15 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K020556.
How does its category compare?
All LRG devicesLRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LRG
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LRG
144in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRG
1in 2025
MAUDE reports naming product code LRG, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 4 | 144 | 0 | 11 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 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. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert.…
Read the full statement (115 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. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert.
This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 μg/mL, to the test panel.
The organisms which may be used for Linezolid susceptibility testing in this panel are:
Streptococcus pneumoniae including multi-drug resistant strains
Streptococcus pyogenes
Streptococcus agalactiae
Viridans group streptococci
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/K111677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111677: Microscan (R) Microstrep Plus (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111677
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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