# K253442: EarliPoint Assessment

- Pathway: 510(k) (Traditional)
- Applicant: Earlitec Diagnostics
- Decided: Mar 5, 2026 after 155 days
- Product code: QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid)
- Device class: 2
- Regulation: 21 CFR 882.1491
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN200069 (2021). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243891: EarliPoint System, Earlitec Diagnostics (2025) Summary page 5.

## Indications for use
The EarliPoint Assessment device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 95 months (7 years), who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.

Source page: https://510kreport.com/device/K253442
Methodology: https://510kreport.com/methodology