510(k) · Cleared
ClearedMicroscan Dried Gram-Postive Mic/Combo Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Helathcare Diagnostics, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial
Cleared on Nov 8, 2013 as substantially equivalent to K003619 (Dade Microscan, Inc., 2001) after a 189-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 8, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- LTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003619 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003619 Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 2001
- This deviceK131275 Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003619 | Dried Gram-Positive Mic/Combo Panels | Dade Microscan, Inc. | 2001 | — |
| 0 (this device) | K131275 | Microscan Dried Gram-Postive Mic/Combo Panels | Siemens Helathcare Diagnostics, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K003619 | Dried Gram-Positive Mic/Combo Panels | 2001 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K003619.
How does its category compare?
All LTT devicesLTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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 (142 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 antimicrobial Tigecycline at concentrations of 0.12 - 8 mcg/ml to the test panel. MicroScan® Dried Gram-Positive Tigecycline is a qualitative test.
Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Enterococcus faecalis (vancomycin-susceptible isolates)
Staphylococcus aureus (methicillin-susceptible and -resistant isolates)
Active in vitro but clinical significance unknown:
Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates)
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/K131275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131275: Microscan Dried Gram-Postive Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131275
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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