| K-number | K240402 |
| Device name | Cito CBC System |
| Applicant | Cytochip, Inc. |
| Product code | GKZ |
| Device class | Class II |
| Decision date | Feb 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
The Cito CBC System is an automated hematology analyzer that performs complete blood count (CBC) testing on whole blood anticoagulated with K2EDTA. It measures 16 parameters including white blood cell count, red blood cell count, platelet count, hemoglobin, hematocrit, mean corpuscular volume, and a 5-part white blood cell differential. The device is not indicated for oncology patients, critically ill patients, or children under 2 years old.
Both the Cito CBC System and predicate device (Sysmex XN-Series) use flow cytometry for cell counting and differential analysis, employing a semiconductor laser as the light source with fluorescence and light scattering detection. Both use photometry for hemoglobin measurement and combine flow cytometry and photometry signals to quantify hematocrit and mean corpuscular volume. The main differences are that the Cito CBC has lower throughput (7 vs. 100 samples/hour) and smaller sample volume (15-20 μL vs. 88 μL), with the predicate offering additional parameters and body fluid analysis modes not claimed by the new device.
CLSI EP05-A3 (precision and reproducibility), CLSI EP06 Ed2 (linearity), CLSI EP17-A2 (limit of quantification), CLSI H26-A2 (measuring range and method comparison), CLSI EP07 Ed3 (interference), CLSI EP32-R (metrological traceability), CLSI H20-A2 (flagging comparison), and CLSI EP28-A3c (reference intervals).
The device is substantially equivalent because it uses identical technological principles (flow cytometry and photometry) as the predicate for the same core CBC parameters and intended use in whole blood diagnostics. Comprehensive verification and validation testing across non-clinical studies (precision, reproducibility, linearity, interference, stability) and clinical studies (method comparison with 481 samples, flagging agreement with 1,082 samples) demonstrated that the Cito CBC System performs comparably to the Sysmex XN analyzer across the reportable ranges and clinically relevant sample populations, meeting acceptance criteria for all parameters.
View the full FDA submission: accessdata.fda.gov