Not Cleared Direct

DEN240032 - APO-Easy Genotyping kit (FDA 510(k) Clearance)

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

DEN240032 · Firalis SA · Immunology device
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Jun 2025
Decision
356d
Days
Class 2
Risk

DEN240032 is an FDA 510(k) submission (not cleared) for the APO-Easy Genotyping kit. Classified as Neurologic Disease Risk Assessment Molecular Test (product code SFC), Class II - Special Controls.

Submitted by Firalis SA (Huningue, FR). The FDA issued a Not Cleared (DENG) decision on June 12, 2025 after a review of 356 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5850 - the FDA immunology 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: Regulatory edge-case submission. High predicate equivalence gap. With 356 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 Firalis SA devices

Submission Details

510(k) Number DEN240032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 21, 2024
Decision Date June 12, 2025
Days to Decision 356 days
Submission Type Direct
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 104d · This submission: 356d
Pathway characteristics

Device Classification

Product Code SFC Neurologic Disease Risk Assessment Molecular Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5850
Definition A Neurologic Disease Predisposition Risk Assessment System Is A Prescription In Vitro Diagnostic Device Intended To Detect Or Measure Dna, Rna, Or Protein Variants In Human Specimens. The Measurements Aid In The Evaluation Of The Risk Of Developing A Neurologic Disease In Patients Presenting With Symptoms And/or With Disease-associated Risk Factors To Aid In Patient Management, In Conjunction With Other Laboratory And Clinical Information.
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 Immunology devices follow this clearance model.