Device class
Class II
Regulation 882.1491
Total clearances
6
2021-06-02 → 2026-03-05
Definition
What is Pediatric Autism Spectrum Disorder Diagnosis Aid
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 details
Medical specialty
Neurology
Regulation number
882.1491
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Earlitec Diagnostics
|
4 |
1 |
2026-03-05 |
|
Cognoa, Inc. |
2 |
0 |
2025-04-11 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 96160 |
CPT
|
— |
High
|
Administration of patient-focused cognitive behavioral intervention/management; standard code for autism spectrum disorder assessment aids |
| 96158 |
CPT
|
— |
Medium
|
Health and behavior assessment; applicable for developmental disorder diagnostic tools |
Pulse
Most recent 510(k) clearances