De Novo · Granted
GrantedVerigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · PAM Gram-Positive Bacteria And Their Resistance Markers
Granted on Jun 26, 2012 as a new device type through De Novo after an 11-day review. 14 later devices descend from it.
- Decided
- Jun 26, 2012
- Review
- 11 days
- Class
- Class II
- Product code
- PAM
- Recalls
- None
14 later devices descend from it, 2 citing it directly.
- This deviceDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 2 of its ownK182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · 2 generations on · 2 of its ownK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP)…Genmark Diagnostics, Incorporated · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122514Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · cites it directly12descendants
- K130914Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · 2 generations on9descendants
- K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelGenmark Diagnostics, Incorporated · 2018 · 3 generations on2descendants
- K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · 2 generations on2descendants
- K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, Incorporated · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| +1 | 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 |
| +3 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +2 | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | 8 |
| +3 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAM? 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 PAM device
- #1 K254194 QIAstat-Dx BCID GPF Plus AMR Panelscore 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (14)
See all 142 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122514 (Nanosphere, Inc., 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All PAM devicesPAM Gram-Positive Bacteria And Their Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PAM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAM
Too few PAM 510(k)s in any year since 2007 to give a median.
Recalls per year · PAM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAM
75in 2025
MAUDE reports naming product code PAM, 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 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 3 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 106 |
| 2024 | 0 | — | 0 | 422 |
| 2025 | 1 | — | 0 | 75 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/DEN120014 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN120014
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026