510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QPFClass II

Pediatric Autism Spectrum Disorder Diagnosis Aid

21 CFR 882.1491 / Neurology
FDA source (opens on fda.gov)

QPF is the FDA product code for Pediatric Autism Spectrum Disorder Diagnosis Aid, a class II device type, regulated under 21 CFR 882.1491. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QPF
Device name
Pediatric Autism Spectrum Disorder Diagnosis Aid
FDA 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.
Regulation
21 CFR 882.1491
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code QPF

By decision year
6 clearances under product code QPF with a decision year between 2021 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QPF by decision year
YearClearances
20211
20221
20231
20252
20261

Applicants with the most clearances

Product code QPF
Applicants holding the most 510(k) clearances under product code QPF
ApplicantClearances
Earlitec Diagnostics4
Cognoa, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code