QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid Class II
FDA product code QPF covers "Pediatric Autism Spectrum Disorder Diagnosis Aid", a Class II medical device regulated under 21 CFR 882.1491. Submissions are reviewed by the Neurology panel. At least 6 recent 510(k) clearances have been granted under this product code.
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 | Mar 5, 2026 |
| K243558 | Cognoa | Canvas Dx | Apr 11, 2025 |
| K243891 | Earlitec Diagnostics | EarliPoint System | Mar 26, 2025 |
| K230337 | Earlitec Diagnostics | EarliPoint | Jun 29, 2023 |
| K213882 | Earlitec Diagnostics | EarliPoint System | Jun 8, 2022 |
| DEN200069 | Cognoa | Cognoa ASD Diagnosis Aid | Jun 2, 2021 |