510(k) · Cleared
ClearediC-GN iC-Cassette for use on the iC-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icubate, Inc. · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Jun 28, 2019 as substantially equivalent to K132843 (Nanosphere, Inc., 2014) after a 134-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Jun 28, 2019
- Review
- 134 days
- Class
- Class II
- Product code
- PEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN120014 (2012). No later device cites it as a predicate yet.
- Root · 4 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 3 generations backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- 2 generations backK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- 1 generation backK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · Recalled
- This deviceK190341 iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −3 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| −2 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| −1 | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | 8 |
| 0 (this device) | K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | 2019 | — |
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 PEN? 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 PEN device
- #1 K262168 QIAstat-Dx BCID GN Plus AMR Panelscore 12.1 · 1 generation · 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 |
|---|---|---|---|
| * | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Summary page 4…stic iC‐GN Assay™ for use on the iC‐System™ Culture Nucleic Acid Test (GC‐GN) (New Device) K132843 (Predicate Device)… | 2014 |
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 7 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K132843.
How does its category compare?
All PEN devicesPEN Gram-Negative Bacteria And Associated Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PEN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEN
Too few PEN 510(k)s in any year since 2007 to give a median.
Recalls per year · PEN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEN
13in 2025
MAUDE reports naming product code PEN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 1 | 4 |
| 2021 | 0 | — | 1 | 15 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The iCubate, Inc. iC‐GN Assay™ for use on the iC‐System™ is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC‐GN Assay™ is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. Cultures demonstrating mixed Gram stain results should not be tested on the assay. The…
Read the full statement (243 words)
The iCubate, Inc. iC‐GN Assay™ for use on the iC‐System™ is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC‐GN Assay™ is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. Cultures demonstrating mixed Gram stain results should not be tested on the assay. The iC‐GN Assay™ is validated for use with select BACTEC™, BacT/ALERT® and VersaTREK® blood culture bottles. The iC‐GN Assay™ is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.
The iC‐GN Assay™ detects target DNA and identifies the following:
Bacterial Genera and Species Resistance Markers
Acinetobacter baumannii complex
Enterobacter cloacae complex KPC (blaKPC)‐ associated with resistance to carbapenems
Escherichia coli NDM (blaNDM)‐ associated with resistance to carbapenems
Klebsiella oxytoca CTX‐M group 1(blaCTX‐M group 1)‐ associated with resistance to extended spectrum beta‐lactams
Klebsiella pneumoniae
Pseudomonas aeruginosa
Proteus species
Serratia marcescens
In mixed growth, the iC‐GN Assay™ does not specifically attribute detection of KPC, NDM, or CTX‐M group 1 to a specific genera or species.
Sub‐culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by the iC‐GN Assay™, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.
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/K190341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190341: iC-GN iC-Cassette for use on the iC-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190341
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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