Not Cleared Direct

DEN180001 - IDx-DR (FDA 510(k) Clearance)

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

DEN180001 · Idx, LLC · Ophthalmic device
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Apr 2018
Decision
89d
Days
Class 2
Risk

DEN180001 is an FDA 510(k) submission (not cleared) for the IDx-DR. Classified as Diabetic Retinopathy Detection Device (product code PIB), Class II - Special Controls.

Submitted by Idx, LLC (Iowa City, US). The FDA issued a Not Cleared (DENG) decision on April 11, 2018 after a review of 89 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1100 - the FDA ophthalmic 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 Ophthalmic review framework.

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Submission Details

510(k) Number DEN180001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 12, 2018
Decision Date April 11, 2018
Days to Decision 89 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics

Device Classification

Product Code PIB Diabetic Retinopathy Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1100
Definition A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions.
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 Ophthalmic devices follow this clearance model.