Athelas One
Athelas One measures white blood cell count and neutrophil percentage in capillary or K2EDTA venous whole blood. It is an in vitro diagnostic system for clinical laboratories and point of…
Athelas One measures white blood cell count and neutrophil percentage in capillary or K2EDTA venous whole blood. It is an in vitro diagnostic system for clinical laboratories and point of care settings, limited to adults aged 21 years or older and used with Athelas One test strips.
The strip stains the blood and spreads it into a single cell layer inside a microfluidic chamber. The instrument captures images, and computer vision analysis counts and classifies the cells. A companion tablet or mobile app controls the device and displays results.
Installation Conditions
The instrument remains stationary in a location protected from vibration and accessible to authorized staff. It requires an internet connection for cloud processing, and the device and strips are kept at 68 to 77 degrees Fahrenheit.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Athelas, United States |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K181288 |
| Record published | 2019-03-26 |
| Record revised | 2024-05-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 850-00001-00 | In distribution | ||
| 850-00002-00 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243348 | 2026-02-06 |
| K200828 | 2022-03-22 |
| K181288 | 2018-11-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.