# DEN180030: QMS Plazomicin Immunoassay

- Pathway: De Novo (Direct)
- Applicant: Microgenics Corporation
- Decided: Nov 19, 2018 after 147 days
- Product code: QDR (Plazomicin Test System, Immunoassay)
- Device class: 2
- Regulation: 21 CFR 862.3460
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The QMS Plazomicin Immunoassay is intended for the quantitative determination of plazomicin in human K2-EDTA plasma on automated clinical chemistry analyzers. The assay results obtained should only be used as an aid in the management of patients with complicated urinary tract infection (cUTI) receiving plazomicin therapy. The assay should only be used in conjunction with information available from clinical evaluations and other diagnostic procedures.

Source page: https://510kreport.com/device/DEN180030
Methodology: https://510kreport.com/methodology