Working with the FDA from Day One
Athelas has collected large amounts of clinical data about our device, all submitted to the FDA currently under review.
FDA Class 2
Submitted
Athelas has conducted clinical studies meant to show equivalence to the FDA Class 2 predicates in the field of Cell counting - these are currently under evaluation by the FDA. Further at-home studies are being conducted for OTC designation.
Clinically Validated
Precision and Accuracy
We take accuracy and transparency seriously. Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex 500.
Athelas Class 1 Technology
Automated Cell Staining Mechanism
KPA
Under FDA product code KPA Athelas has developed a staining mechanism
to interface with blood cells and highlight them for morphological analysis.
All development and production of this technology has been conducted in regulation
with the assigned FDA regulatory reference number 864.3800.
Hemacytometer Representation and Collection Apparatus
GKM and GHO
Under FDA product codes GKM and GHO Athelas has developed a counting mechanism to collect and
flow cells into Statistically Representative Field of Views for analysis.
All development and production of this technology has been conducted in regulation with the assigned FDA regulatory reference number 864.6160.
Imager
IBJ
Under FDA product codes IBJ Athelas has developed a portable optical unit for sample imaging.
All development and production of this technology has been conducted inregulation with the assigned FDA regulatory reference number 864.3600.
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