QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid Class II
Classification Details
- Product Code
- QPF
- Device Class
- Class II
- Regulation Number
- 882.1491
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253442 | earlitec diagnostics | EarliPoint Assessment | March 5, 2026 |
| K243558 | cognoa | Canvas Dx | April 11, 2025 |
| K243891 | earlitec diagnostics | EarliPoint System | March 26, 2025 |
| K230337 | earlitec diagnostics | EarliPoint | June 29, 2023 |
| K213882 | earlitec diagnostics | EarliPoint System | June 8, 2022 |
| DEN200069 | cognoa | Cognoa ASD Diagnosis Aid | June 2, 2021 |