Not Cleared Direct

DEN180007 - Miris Human Milk Analyzer (FDA 510(k) Clearance)

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

DEN180007 · Miris AB · Chemistry device
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Dec 2018
Decision
312d
Days
Class 2
Risk

DEN180007 is an FDA 510(k) submission (not cleared) for the Miris Human Milk Analyzer. Classified as Breast Milk Macronutrients Test System (product code QEI), Class II - Special Controls.

Submitted by Miris AB (Uppsala, SE). The FDA issued a Not Cleared (DENG) decision on December 21, 2018 after a review of 312 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1493 - the FDA in vitro diagnostics and chemistry 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: Regulatory edge-case submission. High predicate equivalence gap. With 312 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Miris AB devices

Submission Details

510(k) Number DEN180007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 12, 2018
Decision Date December 21, 2018
Days to Decision 312 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 88d · This submission: 312d
Pathway characteristics

Device Classification

Product Code QEI Breast Milk Macronutrients Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1493
Definition A Breast Milk Macronutrient Test System Is A Device Intended To Quantitatively Measure Fat, Protein, And Total Carbohydrate Content In Human Breast Milk. These Measurements, In Conjunction With Other Clinical Assessments, May Be Used To Aid In The Nutritional Management Of Infants.
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 Chemistry devices follow this clearance model.