Not Cleared Direct

DEN240080 - Biolinq Shine Autonomous Time-in-Range Microsensor (FDA 510(k) Clearance)

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

DEN240080 · Biolinq Incorporated · Chemistry device
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Sep 2025
Decision
270d
Days
Class 2
Risk

DEN240080 is an FDA 510(k) submission (not cleared) for the Biolinq Shine Autonomous Time-in-Range Microsensor. Classified as Glucose Range Monitoring System (product code SFU), Class II - Special Controls.

Submitted by Biolinq Incorporated (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 23, 2025 after a review of 270 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1359 - 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. Elevated predicate reliance profile. With 270 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.

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Submission Details

510(k) Number DEN240080 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 27, 2024
Decision Date September 23, 2025
Days to Decision 270 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 88d · This submission: 270d
Pathway characteristics

Device Classification

Product Code SFU Glucose Range Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1359
Definition A Glucose Range Monitoring System (grm) Is Intended To Automatically Measure Glucose In The Body And Provide Qualitative Or Semi-quantitative Information About Glucose Levels Or Trends Continuously Or Frequently. Grm Systems Are Intended To Support General User Awareness Of Glucose Ranges Related To Glycemic Control. Outputs From Grm Systems Do Not Represent Quantitative Glucose Concentration Values And Grm Systems Are Not Intended To Be Used For Acute Medical Decision-making, Such As Insulin Dosing Or Medication Adjustment.
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.