# K240402: Cito CBC System

- Pathway: 510(k) (Dual Track)
- Applicant: Cytochip, Inc.
- Decided: Feb 3, 2025 after 360 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112605: Sysmex XN-Series, Sysmex America, Inc. (2012) Summary page 6.

## Indications for use
The Cito CBC system is a quantitative automated hematology analyzer intended for in-vitro diagnostic use to determine the following parameters with whole blood anticoagulated with K2EDTA (Venous): - CBC parameters: white blood cell count (WBC), red blood cell count (RBC), platelet count (PLT), hemoglobin concentration (HGB), hematocrit (HCT), and mean corpuscular volume (MCV); - 5-Part WBC Differential (WBC Diff): neutrophil count and percentage (NEUT and NEUT%), lymphocyte count and percentage (LYMPH and LYMPH%), monocyte count and percentage (MONO and MONO%), eosinophil count and percentage (EO and EO%), basophil count and percentage (BASO and BASO%). It is not indicated for use in diagnosing or monitoring of oncology patients, critically ill patients, or children under the age of 2 years.

Source page: https://510kreport.com/device/K240402
Methodology: https://510kreport.com/methodology