# K112424: Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Dec 16, 2011 after 115 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“081'920!'”).
- (no number) Xpert MRSA/SA Blood Culture Assay (Cepheid): named in the summary without a submission number
- (no number) S. aureus/CNS PNA FISH Culture Identification Kit (AdvanDx): named in the summary without a submission number
- (no number) Phoenix Gram Positive (GP) Panel - Phoenix Automated Microbiology System (Cefoxitin) (Becton-Dickinson): named in the summary without a submission number
- (no number) Verigene RVNATsp Test (Nanosphere): named in the summary without a submission number

## Indications for use
The Verigene® Staphylococcus Blood Culture (BC-S) Nucleic Acid Test 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 bacterial species Staphylococcus aureus ("SA") and Staphylococcus epidermidis ('SE') which may cause bloodstream infection (BSI). In addition, the BC-S test detects the mecA resistance marker inferring mecA-mediated methicillin/oxacillin resistance. In mixed growth, the BC-S Test does not specifically attribute mecA-mediated methicillin/oxacillin resistance to either SA or SE. The BC-S test is performed directly on positive blood culture using BACTEC™ Plus Aerobic/F and BacT/ALERT FA FAN® Aerobic blood culture bottles, which contain gram-positive cocci in clusters (GPCCL) observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation of mixed growth, association of the mecA gene to an organism, or for epidemiological typing. The BC-S test is indicated for use in conjunction with other clinical and laboratory findings, such as culture, to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor bloodstream infections.

Source page: https://510kreport.com/device/K112424
Methodology: https://510kreport.com/methodology