QPF
- Product code
- QPF
- Device name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1491
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253442 | 2026-03-05 | Earlitec Diagnostics | EarliPoint Assessment | |
| K243558 | 2025-04-11 | Cognoa, Inc. | Canvas Dx | |
| K243891 | 2025-03-26 | Earlitec Diagnostics | EarliPoint System | FDA |
Official FDA classification page: QPF
Classification and pathway per current FDA publications. Data from openFDA (CC0).