# K152470: Great Basin Staph ID/R Blood Culture Panel

- Pathway: 510(k) (Traditional)
- Applicant: Great Basin Scientific, Inc.
- Decided: Mar 25, 2016 after 207 days
- Product code: PAM (Gram-Positive Bacteria And Their Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN120014 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP), Nanosphere, Inc. (2012). 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.

## Recalls of this device
- Dec 12, 2016 · Class II · Z-1051-2017: The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

## Indications for use
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.

Source page: https://510kreport.com/device/K152470
Methodology: https://510kreport.com/methodology