K243891 is an FDA 510(k) clearance for the EarliPoint System. This device is classified as a Pediatric Autism Spectrum Disorder Diagnosis Aid (Class II - Special Controls, product code QPF).
Submitted by Earlitec Diagnostics (Atlanta, US). The FDA issued a Cleared decision on March 26, 2025, 98 days after receiving the submission on December 18, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1491. A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients..
| 510(k) Number | K243891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2024 |
| Decision Date | March 26, 2025 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1491 |
| Definition | A Pediatric Autism Spectrum Disorder Diagnosis Aid Is A Prescription Device That Is Intended For Use As An Aid In The Diagnosis Of Autism Spectrum Disorder In Pediatric Patients. |