De Novo · Granted
GrantedQMS Plazomicin Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · QDR Plazomicin Test System, Immunoassay
Granted on Nov 19, 2018 as a new device type through De Novo after a 147-day review.
- Decided
- Nov 19, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- QDR
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QDR devicesQDR Plazomicin Test System, Immunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDR
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QDR
Too few QDR 510(k)s in any year since 2007 to give a median.
Recalls per year · QDR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QDR
No MAUDE report names QDR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180030 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180030: QMS Plazomicin Immunoassay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180030
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026