Athelas One is an AI-enabled medical device from Athelas Inc. that the U.S. FDA cleared through 510(k) K181288 on November 5, 2018. Its lead review panel is Hematology and its primary product code is GKZ (Counter, Differential Cell).
See also all FDA AI clearances in 2018, top hematology AI devices.
Key facts
| Submission number | K181288 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Athelas Inc. |
| Lead review panel | Hematology |
| Primary product code | GKZ — Counter, Differential Cell |
| Applicant (openFDA) | Athelas, Inc. |
| Applicant location | Cupertino, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.5220 |
| 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. Athelas One went through this pathway (K181288).
openFDA lists it as a Class 2 device under 21 CFR 864.5220. Class II devices are moderate risk and are subject to general and special controls.
Product code GKZ covers 5 devices on the FDA AI list. By decision date, this device is #2 of 5 under that code. Athelas Inc. has 3 AI-enabled devices on the list, and the Hematology panel accounts for 22 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 GKZ)
- Athelas HomeAthelas, Inc. · Hematology
- Athelas HomeAthelas Inc. · Hematology
- Sight OLOSight Diagnostics Ltd. · Hematology
- UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBECKMAN COULTER, INC. · Hematology