DEN240032 is an FDA 510(k) submission for the APO-Easy Genotyping kit. This device is classified as a Neurologic Disease Risk Assessment Molecular Test (Class II - Special Controls, product code SFC).
Submitted by Firalis SA (Huningue, FR). The FDA issued a Not Cleared (DENG) decision on June 12, 2025.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5850. 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..
| 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 | - |
| Product Code | SFC - Neurologic Disease Risk Assessment Molecular Test |
| Device Class | Class II - 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. |