510(k) · Cleared
Recalled · Class II · 2016Great Basin Staph ID/R Blood Culture Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Great Basin Scientific, Inc. · PAM Gram-Positive Bacteria And Their Resistance Markers
Cleared on Mar 25, 2016 as substantially equivalent to DEN120014 (Nanosphere, Inc., 2012) after a 207-day review. Its family tree reaches back 1 generation to 2012. It has been recalled once.
- Decided
- Mar 25, 2016
- Review
- 207 days
- Class
- Class II
- Product code
- PAM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120014 (2012). No later device cites it as a predicate yet.
- Root · 1 generation backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- This deviceK152470 Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc. · 2016
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) | K152470 | Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | 2016 | — |
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2016 | Class II | Z-1051-2017 | Material/Component Contamination | The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN120014.
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. 2016, 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 Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus aureus, Staphylococcus lugdunensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled…
Read the full statement (274 words)
The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus aureus, Staphylococcus lugdunensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled polymerase chain reaction (PCR) for the amplification of specific DNA targets detected by hybridization probes immobilized on a silicon chip surface. The assay is performed directly on positive blood culture specimens identified as positive by continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC). The test may be performed using blood culture bottles. The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level.
The Portrait Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Sub-culturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152470: Great Basin Staph ID/R Blood Culture Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152470
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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