Not Cleared Direct

DEN180030 - QMS Plazomicin Immunoassay (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180030 · Microgenics Corporation · Toxicology device
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Nov 2018
Decision
147d
Days
Class 2
Risk

DEN180030 is an FDA 510(k) submission (not cleared) for the QMS Plazomicin Immunoassay. Classified as Plazomicin Test System, Immunoassay (product code QDR), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Not Cleared (DENG) decision on November 19, 2018 after a review of 147 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3460 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Toxicology review framework.

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Submission Details

510(k) Number DEN180030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 25, 2018
Decision Date November 19, 2018
Days to Decision 147 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics

Device Classification

Product Code QDR Plazomicin Test System, Immunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3460
Definition A Plazomicin Test System Is A Device Intended To Measure Plazomicin In Human Specimens. Measurements Obtained By This Device Are Used In Monitoring Levels Of Plazomicin To Ensure Appropriate Therapy In Patients With Complicated Urinary Tract Infection.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.