# DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)

- Pathway: De Novo (Post-NSE)
- Applicant: Nanosphere, Inc.
- Decided: Jun 26, 2012 after 11 days
- Product code: PAM (Gram-Positive Bacteria And Their Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test (2012), 12 descendants of its own
- 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

Source page: https://510kreport.com/device/DEN120014
Methodology: https://510kreport.com/methodology