Submission Details
| 510(k) Number | K243891 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
EarliPoint System
Mar 2025
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K243891 is an FDA 510(k) clearance for the EarliPoint System, 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 review panel. Regulated under 21 CFR 882.1491.
Device Classification
| 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. |
Manufacturer
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