# K182619: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

- Pathway: 510(k) (Traditional)
- Applicant: Genmark Diagnostics, Incorporated
- Decided: Apr 12, 2019 after 200 days
- Product code: PEN (Gram-Negative Bacteria And Associated 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K262168: QIAstat-Dx BCID GN Plus AMR Panel (2026), 0 descendants of its own
- K213236: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K182619
Methodology: https://510kreport.com/methodology