FDA product code QPF: Pediatric Autism Spectrum Disorder Diagnosis Aid
QPF is the FDA product code for pediatric autism spectrum disorder diagnosis aid. It is a Class II device, regulated under 21 CFR 882.1491 and reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under QPF, 5 in the last five years, from 3 different applicants. The average 510(k) review took 143 days (median 144); 138 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.1491 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QPF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 177 |
| 2023 | 1 | 142 |
| 2025 | 2 | 121 |
| 2026 | 1 | 155 |
Compare with all 510(k) review times · Search every QPF clearance
Top QPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Earlitec Diagnostics | 2 | 2026-03-05 |
| Earlitec Diagnostics, Inc. | 2 | 2023-06-29 |
| Cognoa, Inc. | 1 | 2025-04-11 |
Most recent QPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253442 | Earlitec Diagnostics | EarliPoint Assessment | 2026-03-05 | 155 |
| K243558 | Cognoa, Inc. | Canvas Dx | 2025-04-11 | 144 |
| K243891 | Earlitec Diagnostics | EarliPoint System | 2025-03-26 | 98 |
| K230337 | Earlitec Diagnostics, Inc. | EarliPoint | 2023-06-29 | 142 |
| K213882 | Earlitec Diagnostics, Inc. | EarliPoint System | 2022-06-08 | 177 |
Recalls for QPF devices
openFDA lists no recalls for product code QPF.
Frequently asked questions
What is FDA product code QPF?
QPF is the FDA product code for pediatric autism spectrum disorder diagnosis aid. It is a Class II device, regulated under 21 CFR 882.1491 and reviewed by the Neurology panel.
What device class is QPF?
Class II, regulation 21 CFR 882.1491. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPF?
Across 5 cleared submissions the average was 143 days from receipt to decision (median 144).
Which companies have the most QPF clearances?
Earlitec Diagnostics (2); Earlitec Diagnostics, Inc. (2); Cognoa, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPF
- Run a recall and safety report across every QPF manufacturer
- Watch product code QPF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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