EarliPoint System is an AI-enabled medical device from EarliTec Diagnostics, Inc. that the U.S. FDA cleared through 510(k) K213882 on June 8, 2022. Its lead review panel is Neurology and its primary product code is QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid).
See also all FDA AI clearances in 2022, top neurology AI devices.
Key facts
| Submission number | K213882 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | EarliTec Diagnostics, Inc. |
| Lead review panel | Neurology |
| Primary product code | QPF — Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Applicant (openFDA) | Earlitec Diagnostics, Inc. |
| Applicant location | Atlanta, GA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.1491 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EarliPoint System went through this pathway (K213882).
openFDA lists it as a Class 2 device under 21 CFR 882.1491. Class II devices are moderate risk and are subject to general and special controls.
Product code QPF covers 6 devices on the FDA AI list. By decision date, this device is #2 of 6 under that code. EarliTec Diagnostics, Inc. has 2 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code QPF)
- EarliPoint AssessmentEarlitec Diagnostics · Neurology
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- EarliPoint SystemEarliTec Diagnostics · Neurology
- EarliPointEarliTec Diagnostics, Inc · Neurology
- Cognoa ASD Diagnosis AidCognoa, Inc. · Neurology