# K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Jan 8, 2014 after 120 days
- Product code: PEN (Gram-Negative Bacteria And Associated 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: 3 generations back to DEN120014 (2012). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130914: Filmarray Blood Culture Identification (Bcid) Panel, Biofire Diagnostics, Inc. (2013) Summary page 2.
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test, Nanosphere, Inc. (2012) Summary page 2.

## Most influential descendants
- K243013: LIAISON PLEX Gram-Negative Blood Culture Assay (2025), 0 descendants of its own
- K190341: iC-GN iC-Cassette for use on the iC-System (2019), 0 descendants of its own

## Recalls of this device
- Apr 16, 2025 · Class II · Z-1903-2025: It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
- Feb 15, 2022 · Class II · Z-1109-2022: Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
- Oct 30, 2020 · Class II · Z-2008-2021: Potential for a false-negative result.
- Jun 15, 2020 · Class II · Z-2776-2020: An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
- Jul 9, 2014 · Class II · Z-2236-2014: Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have l
- Apr 17, 2014 · Class II · Z-2170-2014: Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is dis
- Oct 10, 2013 · Class II · Z-2681-2014: 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-2736-2014: 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 Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN detects and identifies the following: Bacterial Genera and Species: Acinetobacter spp.; Citrobacter spp.; Enterobacter spp.; Proteus spp.; Escherichia coli; Klebsiella pneumoniae; Klebsiella oxytoca; Pseudomonas aeruginosa. Resistance Markers: CTX-M (blaCTX-M); KPC (blaKPC); NDM (blaNDM); VIM (blaVIM); IMP (blaIMP); OXA (blaOXA). BC-GN will not distinguish Escherichia coli from Shigella spp. (S. dysenteriae, S. flexneri, S. boydii, and S. sonnei). BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

Source page: https://510kreport.com/device/K132843
Methodology: https://510kreport.com/methodology