CellaVision DC-1, CellaVision DC-1 PPA
CellaVision ABThe CellaVision DC-1 is an automated device that uses artificial intelligence to locate and preclassify white blood cells and characterize red blood cells on peripheral blood smears. It captures microscope images, presents them for operator review, and assists in differential blood cell counting, helping clinical laboratories perform in-vitro hematology analysis more efficiently and accurately.
Intended Use
CellaVision DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in clinical laboratories, used for differential count of white blood cells, red blood cell morphology characterization, and platelet estimation.
Technology
The device consists of a motorized microscope with LED illumination, a digital color camera, XY stage, an integrated computer running CellaVision DM Software using convolutional neural networks for AI-based preclassification and precharacterization of blood cells from stained peripheral blood smears.
Performance
Performance testing included clinical studies comparing the DC-1 to the predicate DM1200 device across multiple labs, demonstrating equivalence in white blood cell differential counts, red blood cell morphology characterization, and platelet estimates. Software verification, electromagnetic compatibility, repeatability, reproducibility, and clinical accuracy studies showed the device is safe and effective.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/6/2020
7 months - 2
FDA Approval
10/16/2020
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.