510(k) · Cleared
ClearedMicroscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Sep 10, 2010 as substantially equivalent to K032706 (Dade Behring, Inc., 2004) after a 113-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 10, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- LRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032706 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK032706 Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem…Dade Behring, Inc. · 2004
- This deviceK101425 Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesSiemens Healthcare Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032706 | Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K101425 | Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series | Siemens Healthcare Diagnostics | 2010 | — |
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 |
|---|---|---|---|
| * | K032706 | Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/MLSummary page 1…Notification: New antimicrobial - Doripenem Predicate device: MicroScan Dried Gram-Negative MIC/Comnbo Panels - Ertapenem (K(032706) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative a… | 2004 |
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.
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. 2010, 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® Dried Gram-Negative 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-negative bacilli. After inoculation, panels are incubated for 16 -20 hours at 350 C ±1- I C in a non-C02 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular…
Read the full statement (108 words)
The MicroScan® Dried Gram-Negative 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-negative bacilli. After inoculation, panels are incubated for 16 -20 hours at 350 C ±1- I C in a non-C02 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Doripenem at concentrations of 0.008 to 32 mcg/mI to the test panel.
The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are:
Acinetobacter baumanti
Escherichia coli
Kiebsiellapneumoniae
Proteusmnirabilis
Pseudomnonas aeruginosa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101425: Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101425
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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