510(k) · Cleared
Recalled · Class II · 2024Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test
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
Cleared on Sep 19, 2012 as substantially equivalent to DEN120014 (Nanosphere, Inc., 2012) after a 33-day review. Its family tree reaches back 1 generation to 2012. 12 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 19, 2012
- Review
- 33 days
- Class
- Class II
- Product code
- PAM
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120014 (2012). 12 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- This deviceK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · cites it directly · 2 of its ownK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP)…Genmark Diagnostics, Incorporated · 2018
- Descendant · 2 generations on · 1 of its ownK143171 FilmArray Blood Culture Identification (BCID) Panel for use with the…Biofire Diagnostics, LLC · 2015 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130914Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · cites it directly9descendants
- K182690ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelGenmark Diagnostics, Incorporated · 2018 · 2 generations on2descendants
- K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · cites it directly2descendants
- K181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, Incorporated · 2018 · 2 generations on1descendant
- K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| 0 (this device) | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | — |
| +1 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| +2 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +1 | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | 8 |
| +2 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| +2 | K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray… | Biofire Diagnostics, LLC | 2015 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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
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 |
|---|---|---|---|
| * | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) Our reading of the summary gave K113450, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120014, Verigene Gram Positive Blood Culture Nucleic Acid Test… (Nanosphere, Inc.), granted Jun 26, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2012 |
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Jun 20, 2024 | Class II | Z-2533-2024 | Under Investigation by firm | Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. |
| Nov 7, 2023 | Class II | Z-0500-2024 | Under Investigation by firm | Potentially defective utility trays in the reagent kits. |
| Oct 30, 2020 | Class II | Z-2007-2021 | Device Design | Potential for a false-negative result. |
| Jun 15, 2020 | Class II | Z-2775-2020 | 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. |
| Dec 26, 2018 | Class III | Z-0822-2019 | Under Investigation by firm | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. |
| Sep 14, 2018 | Class II | Z-0445-2019 | Nonconforming Material/Component | Potential to lead to a false negative results. |
| Oct 10, 2013 | Class II | Z-2683-2014 | 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-2735-2014 | 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?
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 | — |
What is it indicated for?
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which…
Read the full statement (218 words)
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
BC-GP detects and identifies the following bacterial genera and species:
Staphylococcus spp. Streptococcus spp. Enterococcusfaecalis
Staphylococcus aureus Streptococcus pneumioniae Enterococcusfaecium
Staphylococcus epidermidis Streptococcus pyo genes
Staphylococcus lugdunensis Streptococcus agalactiae Listeria spp.
Streptococcus anginosusgroup
In addition, BC-UP detects the miecA resistance marker; inferring mecA-mediated methicillin resistance, and the vanA and vanB resistance markers, inferring vanA4/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or Ef aecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis.
BC-UP is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identification of organisms not detected by BC-GP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122514
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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