# K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Sep 19, 2012 after 33 days
- Product code: PAM (Gram-Positive Bacteria And Their Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: 8 (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.
12 later devices descend from it; 4 cite it directly.
0 of 14 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.

## Most influential descendants
- K130914: Filmarray Blood Culture Identification (Bcid) Panel (2013), 9 descendants of its own
- K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (2018), 2 descendants of its own
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) (2014), 2 descendants of its own
- K181663: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (2018), 1 descendant of its own
- K143171: FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (2015), 1 descendant of its own

## Recalls of this device
- Jun 20, 2024 · Class II · Z-2533-2024: 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: Potentially defective utility trays in the reagent kits.
- Oct 30, 2020 · Class II · Z-2007-2021: Potential for a false-negative result.
- Jun 15, 2020 · Class II · Z-2775-2020: 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: 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: Potential to lead to a false negative results.
- Oct 10, 2013 · Class II · Z-2683-2014: 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 pro
- Jun 17, 2013 · Class II · Z-2735-2014: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K122514
Methodology: https://510kreport.com/methodology