510(k) · Cleared
Recalled · Class II · 2025Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Jan 8, 2014 as substantially equivalent to K130914 (Biofire Diagnostics, Inc., 2013) and 1 other predicate after a 120-day review. Its family tree reaches back 3 generations to 2012. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 8, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- PEN
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN120014 (2012). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 2 generations backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- 1 generation backK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- This deviceK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK243013 LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation · 2025
- Descendant · cites it directly · 0 of its ownK190341 iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −2 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| −1 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| 0 (this device) | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | — |
| +1 | K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation | 2025 | — |
| +1 | K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K130914 | Filmarray Blood Culture Identification (Bcid) PanelSummary page 2…inga! Organismis, Nucleic Acid-Based Assay 001 Real Time Nucleic Acid Amplification System P~redicate Devices: FilmnArray Blood Culture Identification (BCID) Panel (K1309 14, Biofire Diagnostics) \Kcrigene Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test (K122514 / KI 13450) Intended Use: The Veri… | 2013 |
| * | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestSummary page 2…P~redicate Devices: FilmnArray Blood Culture Identification (BCID) Panel (K1309 14, Biofire Diagnostics) \Kcrigene Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test (K122514 / KI 13450) Intended Use: The Verigeneg Gramn Negative Blood Culture Nucleic Acid Test (BC-ON). performed using the samnple-to-re… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2025 | Class II | Z-1903-2025 | Under Investigation by firm | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. |
| Feb 15, 2022 | Class II | Z-1109-2022 | Under Investigation by firm | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. |
| Oct 30, 2020 | Class II | Z-2008-2021 | Device Design | Potential for a false-negative result. |
| Jun 15, 2020 | Class II | Z-2776-2020 | Device Design | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. |
| Jul 9, 2014 | Class II | Z-2236-2014 | Under Investigation by firm | Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic… |
| Apr 17, 2014 | Class II | Z-2170-2014 | Under Investigation by firm | Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN… |
| Oct 10, 2013 | Class II | Z-2681-2014 | Nonconforming Material/Component | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays. |
| Jun 17, 2013 | Class II | Z-2736-2014 | Process change control | There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K243013 (Luminex Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130914.
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. 2014, 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 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain…
Read the full statement (206 words)
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain.
BC-GN detects and identifies the following:
Bacterial Genera and Species: Acinetobacter spp.; Citrobacter spp.; Enterobacter spp.; Proteus spp.; Escherichia coli; Klebsiella pneumoniae; Klebsiella oxytoca; Pseudomonas aeruginosa.
Resistance Markers: CTX-M (blaCTX-M); KPC (blaKPC); NDM (blaNDM); VIM (blaVIM); IMP (blaIMP); OXA (blaOXA).
BC-GN will not distinguish Escherichia coli from Shigella spp. (S. dysenteriae, S. flexneri, S. boydii, and S. sonnei).
BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for 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/K132843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132843
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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